Regulatory Specialist Resume Samples

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C Thiel

Camryn

Thiel

38043 Gordon Locks

Dallas

+1 (555) 813 1512

38043 Gordon Locks

Dallas

Phone

p +1 (555) 813 1512

Experience Experience

New York, NY

Regulatory Specialist

New York, NY

Collier-Lehner

New York, NY

Regulatory Specialist

Contribute to enhanced regulatory awareness and culture in KBC Bank Ireland
Assist with the coordination of supervisory reviews and/or inspections carried out by KBCI's Regulatory Authorities
Provide guidance to the business to prepare for onsite inspections
Assist in the coordination of responses to requests for information from KBCI's Regulatory Authorities
Complete Risk Control Assessments for the Regulatory Management team
Ensure KBCI compliance with the Fitness & Probity Regime including PCF submissions
Serve as Novella liaison with central IRBs

Houston, TX

Wireless Regulatory Specialist

Houston, TX

Macejkovic, Denesik and Langworth

Houston, TX

Wireless Regulatory Specialist

Partner with submarket personnel to apply rule interpretations and provide guidance in order to make independent and sound decisions
Establish and maintain open communications with submarket employees and various governmental agencies including regular interaction with management
With guidance from team leads, supervisor and/or manager prepare and respond to Status Requests from the FAA
Act a team lead while providing guidance on various projects
Review Field Strength Agreements to ensure that they are correct and fully executed
Develop and implement processes for regulatory and engineering strategies to expedite service while ensuring compliance with governing rules
Phase 1 and Phase 2 ordering and management

present

New York, NY

Associate Regulatory Specialist

New York, NY

Windler-Legros

present

New York, NY

Associate Regulatory Specialist

present

Providing input for product labeling
Provide guidance on prospective classifications for experimental products
Providing guidance on prospective classifications for experimental products
Provide Hazard Communication support to Ecolab business units
Provides attention to detail to minimize internal and external complaints
Develop materials and participate in activities with Ecolab customers
Understand the importance of meeting department performance targets

Education Education

Bachelor’s Degree in Biology

Howard University

Bachelor’s Degree in Biology

Skills Skills

Knowledge of and ability to use Microsoft Office programs, Versa: Regulation, and OnBase
Basic knowledge of Chapter 475 F.S. and Fla. Adm. Code 61J2
Basic knowledge of Chapter 119 and 455, F.S. relating to public record requests
Strong team player as well as the ability to work on own initiative
Good Knowledge of cosmetic and chemical regulations
An ability to build strong working relationships
Ability to work with all levels of the organization and external stakeholders in a professional manner
Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international

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Business Risk & Regulatory Specialist Resume Examples & Samples

Bachelor’s degree in Business, Finance, or a related field with 7+ years of related financial services experience
Require experience in controls creation and monitoring, preparation of policies and procedures, risk identification and monitoring, and/or compliance and oversight functions; preferably in asset management or with a federal regulator
3+ years of business experience specific to asset management
3+ years’ experience with financial services risk management, including development and reporting on KRIs and KPIs, risk cataloguing and monitoring, supplier risk management, business continuity planning, etc
Experience with model governance processes
Experience working with or for federal regulators
Superior management and execution skills dealing with multiple stakeholders in a complex, fast paced environment
Strong process orientation and the ability to adapt well to, and initiate change in the organization
Excellent communication skills and comfort dealing with executives and staff at all levels
Strong ability to think critically, comprehend detailed business, technology and risk concepts and develop and defend an independent position based on a pragmatic and balanced assessment
Detail-oriented, with hands-on, roll-up-your sleeves approach
Proficiency in Microsoft 2010 suite, particularly Excel and PowerPoint

Residential Loan Regulatory Specialist Resume Examples & Samples

Prepare the initial GFE and Application Disclosures and review for accuracy. Responsible for highlighting, tabbing and mailing the initial application package to customer
Complete and mail RESPA changed circumstance coversheet and revised GFE and/or TIL
Review and validate that all application disclosures have been properly signed and executed, including CIP forms and Life and Disability acceptance/waiver documentation
After review Appraisal Management Group, print and mail appraisal and AIR document to customers
Ensure the cancel/denied/withdrawn process is completed properly. Confirm the correct HMDA action date and type has been properly coded in MCO
Perform follow up with Loan Officer, Loan Processor and/or Loan Supervisor to ensure Reg B has been met on all files for non originated and incomplete files
Perform closed file quality review prior to shipping to post closing. Ensure documentation is in correct file order and has been executed properly
Complete and mail Notice of Action to customer for counter offers
Review and approve Flood Insurance Policies on all properties determined to reside in a special flood hazard area

On-call Attorney / Regulatory Specialist Resume Examples & Samples

Managing project teams
Assist senior managers on business development
U.S. citizenship is required; security clearances are a plus
Understanding the Federal regulatory development process, including key executive orders and OMB orders and circulars
General personal computer mastery
At least 2-3 years of experience working on projects related to federal regulatory programs and issues and involving research, analysis, and writing

Audit & Regulatory Specialist Resume Examples & Samples

Create, collect and centrally manage deliverables required for successful completion of Audit & Regulatory exams
Counsel IS Program Managers to ensure that all audits are well prepared for and effectively managed
Raise awareness to proper audit processes and effective audit readiness techniques
Maintain continuous improvement of the IS programs while ensuring the appropriate balance exists between control assurances, policy compliance and operational efficiency
Assist IS Program Managers in drafting well-articulated, objective audit findings, responses and corrective actions that effectively diminish and address risks
Coordinate with the Regulatory Audit Management (RAM) team on review of exam draft reports
Serve as a lead contact/central point of communication with the RAM team on IS audit and regulatory matters
Conduct quality assurance reviews of evidentiary materials in support of issue closure before submission to regulators and/or the RAM team
Perform regulatory compliance policy, procedure and control effectiveness test checks and targeted reviews
Assist with the monitoring of regulatory changes, ensuring communication of new requirements and assisting the IS Policy Working Group in creating or revising policies and processes to meet new requirements
At least 3-5 years’ experience, preferably in Risk Management, Information Security or Audit
Previous experience performing internal and/or external audit coordination is an advantage
Quick learner and able to work in a diverse, global environment
In-depth knowledge of technology, security, risk, and compliance best practices
Strong capability in interfacing with both technology and business areas
Excellent communication, written and oral, interpersonal and presentation skills to technical and business audiences in a constantly evolving environment
Customer-oriented, resourceful and enthusiastic
Undergraduate degree required; CISA, CRISC preferred

Collateral Tax Regulatory Specialist Resume Examples & Samples

Respond timely and empathetically to all our customer needs and requests
Comply with all government regulations: notifications, past due taxes, plate exchange, etc
Relates and communicate with different functional areas helping to expedite and improve processes
Document and update systems and processes if needed
Be the main contact point for all local and federal governments to define most effective ptax payment & compliance processes
Can be counted to exceed goals successfully; results oriented; steadyfastly pushes self and others for results
Is dedicated to meeting the expectations and requirements of both internal and external customers; gets first-hand customer information and uses it for improvements in services; acts with customers in mind, establishing and maintaining effective relationships with customers and government authorities, gaining their trust and respect, in compliance with all internal and external regulations
Uses rigorous logic and methods to solve difficult problems with effective solutions, probing all fruitful sources for answers; can see hidden problems, looks beyond the obvious and doesn’t stop at the first answer
Makes decisions in timely manner, sometimes with incomplete information and under tight deadlines and pressure
Can quickly find common ground and solve problems for the good of all, representing his/her own interests and yet being fair with other groups; is team oriented and is able to get consensus and drive change in interdisciplinary teams; is capable of solving problem with peers with minimum noise; is seen as a team player, cooperative, who gains trust and support of peers
Practices attentive and active listening with patience, but also can accurately restate the opinions of other even when there is disagreement
Know personal strengths, weaknesses, opportunities and limits; seeks feedback without being defensive; gains insight from mistakes
Up to two years of relevant work experience in quality, processes, customer care are desirable

Regulatory Specialist On-call Resume Examples & Samples

Assisting in Preparation of Permit Applications and Associated Documentation
Preparing Technical Memos and Documents Related to the Regulatory Compliance field
Conducting impact analyses
Conducting Fieldwork Under the Supervision and Guidance of Senior Staff
Bachelor’s Degree in Environmental Studies, Environmental Engineering or related field
3+ years of consulting or other relevant experience
Excellent organization and communication skills
Excellent writing skills
Proficiency using Microsoft Excel to quantify and summarize environmental data
Familiarity with GIS tools and direct experience working with or as GIS analyst to produce impact maps and figures
Direct experience in CWA Section 404, 401, and/or Lake or Streambed Alteration Agreement permitting, including 404b1 alternatives analyses
Knowledge of CEQA, NEPA, FESA, and/or CESA Compliance
Construction monitoring experience
Wetland Delineation experience
Experience reviewing engineering plans and specifications
Familiarity with Central Valley flora, fauna and wetlands communities

Mifid & Regulatory Specialist EY Financial Services Resume Examples & Samples

You will provide competent technical regulatory advice to our clients in financial institutions
You will identify legal requirements, and implement them in distribution models, service models, processes and business operations
You will demonstrate a pro-active, client-oriented attitude and identify additional sales opportunities
You will act as an interface with our clients, both locally and on EMEIA level, and step up to the challenge of representing EY in front of external parties

Regulatory Specialist Supervisor Resume Examples & Samples

Assists in monitoring customer service productivity in accordance with established policy to assure adherence as well as completeness
Ensures adherence to company policy, procedures, standards, and goals
Experience with handling of regulatory cases (FCC, BBB, PUC, AG, etc.) a plus

Regulatory Specialist Resume Examples & Samples

Contribute to enhanced regulatory awareness and culture in KBC Bank Ireland
Assist in the management of the regulatory relationship including proactive liaison with and answering queries from the Central bank of Ireland, and any other industry body as required)
Assist with the coordination of supervisory reviews and/or inspections carried out by KBCI's Regulatory Authorities
Manage the day to day activities during an onsite inspection and escalate issues to the Head of Regulatory Affairs as appropriate
Provide guidance to the business to prepare for onsite inspections
Assist in the coordination of responses to requests for information from KBCI's Regulatory Authorities
Co-ordinate the various registrations, returns and levies which are required by KBCI's Regulatory Authorities
Complete Risk Control Assessments for the Regulatory Management team
Assist the Head/Director of Regulatory Affairs with ad hoc tasks as and when required
Where appropriate represent the Bank at various regulatory bodies and in the development and formulation of regulatory regulations and policies
Involvement in any projects that require regulatory input including representing regulatory in new and active products committee
Ensure KBCI compliance with the Fitness & Probity Regime including PCF submissions
Enthusiastic, self-starter with a high level of self-motivation
Excellent interpersonal skills
Excellent communication (written and oral) skills
Strong team player as well as the ability to work on own initiative
Excellent time management and prioritizing skills required
Ability to adapt to change and thrive in a dynamic banking environment
An ability to build strong working relationships
Ability to work with all levels of the organization and external stakeholders in a professional manner
A proven ability and focus on results to deliver against challenging objectives, targets and timelines
Excellent report writing skills

Collateral Tax Regulatory Specialist Resume Examples & Samples

Manage change of ownership for sold portfolio
Follow up processes with third party vendors on processes
Can be counted to exceed goals successfully; results oriented; steadfastly pushes self and others for results
Knowledge in English is a plus

Legal Paper Regulatory Specialist Resume Examples & Samples

Proven and progressive experience as a paralegal in a law firm or corporate law environment or proven supervisory and/or management experience or equivalent
Minimum of an Associate’s degree and certificate of completion/diploma from paralegal studies program (preferably ABA approved), or equivalent work experience
Good organizational, analytical, project management and written and verbal communication skills
Understanding of substantive legal concepts, court practices and procedures, legal research and documents, procedures and terminology
Developed managerial, communications, organizational, decision-making, negotiations and customer service skills
Knowledge of products, services, policies and regulations impacting area of responsibility
Proven ability to respond to changing circumstances
Ability to read and interpret most complex legal documents for proper handling
Proficient with personal computers as well as pertinent mainframe systems and software applications
Ability to maintain confidentiality as well as operate pertinent office equipment
Ability to handle multiple tasks in a fast- paced environment
Flexibility to work overtime as required

Senior Regulatory Specialist & Project Manager Resume Examples & Samples

BS/MS/PHD in related discipline
Minimum of 10 demonstrated years of experience in field
Minimum of 5 years demonstrated years of experience managing projects and staff
Experience with business development and program management for transportation clients
Experience completing permit applications under the Clean Water Act (e.g., CWA Section 401, 404, including 404b1 Alternatives Analysis)
Experience completing Lake or Streambed Alteration Agreements (e.g., CDFW Section 1602)
Experience with federal Endangered Species Act (ESA) Consultations pursuant to Section 7 of the ESA and Incidental Take Permit Applications pursuant to Section 2081 of the California ESA
Experience completing permit applications under the California Porter-Cologne Act
Demonstrated ability to manage permit application processes from start to finish
Experience with project and task management including cost and schedule management, proposal development/preparation, staffing allocation and performance management
Experience with business development and client development
Mitigation Planning
Wetland Delineation / Jurisdictional Determinations
Biological Impact Analysis
Competitive Proposal Writing
Demonstrated Business Development Capabilities
Strong analytical, problem-solving and decision making capabilities, including ability to identify existing or potential problems and recommend solutions
Ability to work with all levels of internal staff, as well as outside clients and subconsultants

Audit & Regulatory Specialist Resume Examples & Samples

Leading the challenge review preparation process for TRMIS audit and regulatory findings; this includes critical analysis of resolution actions taken by TRMIS to resolve findings, ensuring controls are designed appropriately and are sustainable
Providing management support on reviews by participating in planning and fieldwork meetings, and facilitating the management response process including reviews of resolution plans and dates for appropriateness
Facilitating meetings with TRMIS, Audit and other TS teams to confirm status updates on findings and proactively resolve issues as required
Building effective working relationships with key stakeholders including auditors, TRMIS partners (e.g. ITS), and TD risk oversight groups
Acting as the primary ARM contact for the TD risk oversight groups on matters pertaining to regulatory exam planning, and status reporting
Communicating/reporting updates to TRMIS Senior Leadership Team regarding pipeline of audits and regulatory exams, and status of findings
Being a key contributor to ARM’s strategic planning and continuous improvement initiatives
Performing ad hoc analysis and participating in regulatory initiatives or special projects as assigned by Senior Manager

Regulatory Specialist on Electrical & Electronic Appliances Resume Examples & Samples

Know and understand all relevant regulatory requirements and trends related to beverage machines (delivery/vending) to support R&D and markets/GMBs
Minimum Master degree
3 – 4 years’ experience working in an international environment in the area of electrical safety / electrical engineering and /or environmental compliance of electrical appliances
Engineer Education background / experience would be a strong asset
Project management experience desirable
Recognized scientific and technical knowledge
Fluent in English, French a bonus

Clinical Trials Regulatory Specialist Resume Examples & Samples

Experience supervising a small group of staff
Experience developing and delivering training
Ideally candidate has developed and deployed new regulatory processes in an organization
Bachelor’s degree and five years of related experience or a combination of relevant education and experience
Excellent inter-personal skills and customer service focus is required
Experience in clinical research management and oversight, including project management in a dynamic research setting
Demonstrated ability to manage multiple projects and staff under varying time constraints
Strong writing skills

Regulatory Specialist Resume Examples & Samples

Bachelor’s degree in Clinical Research/Public Health/ Business or related field
2 years’ experience in regulatory compliance of clinical research projects and project management
Excellent communication skills
Excellent speaking and writing skills
Demonstrated ability to write manuals and procedural documents
Demonstrated ability to give presentations to stakeholders
Knowledge of Clinical Research Study Startup processes including IRB submissions, site feasibility analyses
Experience developing budgets
Experience supervising, training, and/or mentoring new staff or students
Strong leadership skills necessary for determining, recommending, and implementing improvements to policies/processes and best practices
Strong interpersonal skills
Proficiency in Microsoft Office and database applications
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices
Knowledge of medical terminology

Senior Product Regulatory Specialist Resume Examples & Samples

Gaining and applying up-to-date knowledge of pertinent global chemical control regulations including regular monitoring of regulatory literature for changes, and seeking out industry/regulatory information to keep Global Product Regulatory current and offering comments/ input to industry groups
Determining and communicating to external and internal customers the global regulatory status of new and existing chemical products
Preparing notifications and submissions to government agencies and competent authorities with no supervision; communicating with authorities to determine strategies and path forward
Gaining and maintaining proficiency in databases required for the generation and documentation of chemical information and product regulatory compliance
Interfacing with business unit, research and development or other BP staff to acquire technical knowledge concerning BP products, keep BU advised of regulatory changes, and develop strategies for implementation of regulatory programs
Assisting Product Safety Associates and Specialists in chemical control regulation determinations
Leading the training of Global Product Regulatory Associates and Specialists
Acting as a team leader or technical expert coordinating medium to large project teams
Actively participating in trade associations such as ACC and representing BP’s viewpoint in regulatory matters
Managing junior staff newly integrated into the Global Product Regulatory team to continue targeted instruction and training to enhance their assimilation

K-reach Chemical Regulatory Specialist Resume Examples & Samples

Lead and manage all activities relating to the clients' project requirements
Organize consortium activities
Maintain, communicate and manage the consortium planning
Maintain consortium administration (e.g. budget) and organize the communication with other stakeholders (potential new Consortium members, data sharing requests, etc.)
Chair consortium meetings between technicial stakeholders in the taskforces organized and the managerial stakeholders involved or facilitate these meetings
Coordinate the ongoing technical work of the consortium
Solve ongoing and potential issues
Liaise with authorities like ECHA Preparation of Technicial Reports and Proposals; and Marketing support
Bachelor and/or Master degree in Chemical or related engineering disciplines
Minimum 5 years relevant experience within industry or consulting as Project Manager
Proficient in Microsoft Office Suite, including Microsoft Project
Proactive and fast learner, excellent communication skills and good team worker
Excellent command of written and spoken Korean and English

Environmental Regulatory Specialist Resume Examples & Samples

Conduct research and gather information on regulatory requirements (i.e. permit requirements) for energy facility development
Collect natural resource desktop data to evaluate potential impacts from projects
Prepare written and tabular data summarizing the environmental issues associated with a project for technical documents, resource reports, Environmental Assessments, and Environmental Impact Statements, etc
Prepare applications for submittal to federal, state or local environmental regulatory authorities for energy facility development, expansion, maintenance or decommissioning
Prepare scopes of work for environmental tasks to be completed by subcontractors
Manage resolution of resource issues
Manage project tasks as assigned, including directing/guiding associate consultant staff activities
Participate in agency communication and consultation
Attend agency/public meetings
Interact with clients
Assist with business development and proposal preparation
Maintain compliance with corporate Health, Safety and Environment requirements; and
Master’s degree in environmental studies or a natural science field of study
Familiarity with the types of energy facilities and associated environmental issues
Knowledge of the regulations which apply to the energy industry including those implemented by the Federal Energy Regulatory Commission, the U.S. Army Corps of Engineers, U.S. Fish and Wildlife Service, and state agencies
Experience with linear-type development projects
Relevant work experience in multiple states, preferably states in the eastern U.S
Environmental fieldwork skills (i.e. wetland delineation skills, habitat assessments, etc.)
Experience working in and/or managing the work of field survey crews

Senior Regulatory Specialist Medical Devices Based Resume Examples & Samples

Prepare, coordinate and secure all necessary authorizations, registrations and/or documentation needed for regulatory compliance according to MDD 93/42EEC and EN ISO 13485 for Medical Devices
Lead the vigilance process, fulfil incident reporting obligations and prepare related documents and follow-up
Implement registration strategies to secure market authorizations with Notified Bodies to enable EU sale of Medical Devices
Liaise with Notified Bodies and regulatory authorities during Medical Device registration processes during product life cycle on a pan European base
Monitor regulation changes to ensure continued compliance and maintain Medical Device technical files

California Wetland Regulatory Specialist Resume Examples & Samples

Support and lead technical work including complex jurisdictional delineations of waters and wetlands, delineation reports, permitting application packages, biological impact analyses for sections of CEQA or NEPA environmental documents (EA, EIS, MND, EIR, etc) and stand-alone technical reports (NES, BTR, etc.)
Project management and participating as a biologist on habitat restoration projects, botanical surveys, listed species surveys, conservation plans, and habitat management plans
Project and/or task-level management, client management, and leading coordination with resource agencies
Responsible for projects that involve innovative mitigation and conservation planning
Multi-disciplinary teamwork with biologists, planners, landscape architects, and restoration ecologists
Creative integration of natural resource analysis and project design
Master’s Degree in Biology, Wetland Ecology, Natural Resources, or similar related field
Familiarity with complex issues related to wetland ecology, watershed planning, ecological restoration, conservation planning, and/or natural resources planning
Agency consultations under Sections 7 and 10 of ESA and preparing associated documentation
Experience in marketing and business development efforts in pursuit of new projects
Project management skills, including the ability to effectively manage schedule, staff, budget and finances
Experience working with California Coastal Commission

Associate Environmental Regulatory Specialist Resume Examples & Samples

Revise and maintain section’s implementing procedures
Perform Compliance Certification and PCB Change Screening
Coordinate Annual and Impromptu EPA Monitoring Inspections (per 40 CFR 194.21)
Perform regulatory analyses that apply to the WIPP certification, as defined in the WIPP Land Withdrawal Act and 40 CFR 191 and 194
Support the preparation of planned change requests and planned change notices to the EPA in regards to changes in activities or conditions to the WIPP disposal system
Support the preparation of the 2019 Compliance Recertification Application
Gather and evaluate complex technical information and prepare written reports and documents with recommendations to management for solving issues or problems
Analyze procedures, rules, and other requirements to evaluate conflicting or potentially conflicting requirements and areas where reinventing outdated requirements or initiating re-engineering concepts and principles can be considered and initiated
Formulate plans, maintain schedules and logs, and perform various record keeping tasks

Senior Regulatory Specialist / RA Manager Resume Examples & Samples

As one of the department’s regulatory experts, the incumbent is required to provide guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements
In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
Requires the ability to provide solutions based on their own knowledge and industry experience base. Detailed activities include
Provide active and ongoing regulatory guidance to project teams
Document regulatory strategies for product submissions
Facilitate and prepare U.S. regulatory Pre Submission documents for Next Generation Sequencing and PCR assays
Facilitate FDA pre submission meetings
Prepare U.S. regulatory submissions (PMA and 510(k)) for Next Generation Sequencing and PCR assays
Support EU representatives in their creation of CE/IVD Technical Files
Perform regulatory assessment of new and changed products
Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc
Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment
Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures
Participate in business meetings with potential new external partners
Must have a minimum of 5 years of IVD Regulatory Affairs experience
This experience must include either 510(k) or PMA Submissions
Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies
Experience in the balance and application of regulatory requirements
Direct and positive experience in communicating with Regulatory Authorities and Distributors
Regulatory review of promotional marketing materials, press releases, labeling, etc
High energy level; positive attitude; works well under stress
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Willingness to travel (~10-15%)
Comfortable with ambiguity and change

Regulatory Specialist Client Documentation Resume Examples & Samples

Several years of professional experience in a Client Documentation or Compliance role in the financial sector, preferably in Switzerland
Bachelor’s or Master’s degree in business law or comparable areas
Profound understanding of regular initiatives like FATCA, CRS and VSB/CDB
Efficient and resilient
Client- and team-oriented
Fluent in German and in English, other languages are an asset

Drone Product Regulatory Specialist Resume Examples & Samples

Supporting design teams on product safety, and electromagnetic compatibility (EMC) related issues
Manage internal/external laboratories to test products for product safety and regulatory compliance including setup and execution of tests (including ESD testing and EMI/EMC Qualification
Work closely with engineering, validation, and product development teams to ensure compliance to product ecology and regulatory requirements (FCC / CE / UL)
Review specifications, evaluate vendors, analyze test reports and ensure products conform to standards and specifications
Comprehend implications of new technologies or design concepts and ensuring designs will comply with standard quality & reliability requirements
Assessing risks, develop procedures for analysis and design for compliance for computer components, products, and systems
Develop and implement work plan to obtain and/or maintain product regulatory certifications
Develop solutions to problems utilizing formal education and judgment
Utilize end to end product life cycle management process ensuring quality and reliability considerations are built in at each step
B.Sc. in Electrical Engineering
Knowledge of systems engineering and system certification methodologyincluding “V” model implementation
Solid understanding of Product Life Cycle from Product Specification, BOM Analysis, and Global Compliance standards
Capability to decipher codes in the Harmonized Tariff Schedule, and understanding key regulations for Other government agencies; like the Federal Communications Commissions (FCC), Food and Drug Administrations (FDA) and Environmental Protection Agency (EPA) and the related agencies in other countries

Senior Regulatory Specialist Resume Examples & Samples

Legal evaluation of the company products for the intended industry (i.e. food, beverage)
Responsible for the creation, issuance and updating of product documentation. This could include documents such as specifications, allergens, GMO, labeling, country compliance, kosher, halal, SDS, nutritional information, country of origin and other Regulatory documentation to Eatem Foods customers and technical personnel as needed
Maintain the technical data for products manufactured and sold by Eatem Foods
USDA label sketch approvals – responsible for creating and submitting to the agency for approval
Communicate with external governing agencies and trade associations as required
Evaluates formula revisions and communicates labeling modifications to customers
Act as an information resource for both internal and external customers to include education and guidance to affected departments regarding various regulatory topics
Perform root cause analysis for customer complaints related to Regulatory
Perform other duties and special assignments as required

Associate Regulatory Specialist Resume Examples & Samples

Possess knowledge of how to research regulations that apply to product portfolio
Possess communication skills that can relate regulatory topics to non-regulatory audiences (Sales, R&D)
Ability to focus priorities and work under pressure to meet deadlines with minimal supervision
Technical understanding of vendor documentation and regulation research
Provides attention to detail to minimize internal and external complaints
Actively participate and contribute to team building efforts in the department
Understand the importance of meeting department performance targets
Degree in Chemistry, Food Science or other related field, or equivalent experience
Prefer 1-3 years in regulatory compliance for food/beverage, flavor, or animal feed industry
Strong, independent analytical and problem-solving skills

Wireless Regulatory Specialist Resume Examples & Samples

Execute the company procedures to maintain regulatory compliance on the network projects proposed by submarket teams. On average there are 3000 projects per month and these projects make up the bulk of the annual network capital budget
Review and analyze the relevant engineering, technical and regulatory information as submitted by the submarkets using systems such as Airspace, VZReg and Siterra to determine whether proposal will be compliant or whether approvals/grants from the governing agencies is required prior to issuing approvals
Interact daily with the submarket teams to provide guidance and direction on regulatory compliance requirements as defined in our policies
Review Field Strength Agreements to ensure that they are correct and fully executed
Prepare and submit filings to the FCC’s Universal Licensing System (ULS), FAA OEAAA systems and the Departments of Transportation (DOT) when required. Filings would include the following: FAA determination, FCC Antenna Structure Registration (ASR) and Environmental Assessments on an ASR
With guidance from team leads, supervisor and/or manager prepare and respond to Status Requests from the FAA
Assist the Team Leads in the development of regulatory training programs such as on-site workshops, on-line training tools and web meetings regarding FCC rule interpretations and regulatory policies and procedures
Assist team lead, supervisor and/or manager with development and implementation of processes for regulatory and engineering strategies to expedite service while ensuring compliance with governing rules
Participate in training as needed to gain a better understanding of rules and internal processes
Know and understand the principles of the FAA regulations and corresponding FCC rules (Code of Federal Regulations (CFR) Part 17) regarding obstacle evaluation, including identification of heights exceeding minimum instrument flight altitudes, heights exceeding conical surfaces for prescribed slope calculations and obstruction and marking/lighting requirements, including painting guidelines, lighting guidelines and acceptable configurations
Know and understand the principles of the FCC rules (C.F.R. Parts 1, 22, 24 & 27) for all services (700 MHz, AWS, Cellular & PCS). This would include disturbance of AM broadcast station patterns, frequency tolerance, field strength agreement, Effective Radiated Power (ERP) manipulation, international border requirements and Quiet Zones, Height Above Average Terrain (HAAT), bandwidth, power and antenna height limits
Analyze and monitor regulatory information submitted by submarkets in preparation of federal, state and local applications and reports to obtain FAA approvals, FCC grants and state DOT approvals (when required) with guidance from team lead, supervisor or manager as needed
Partner with submarket personnel to apply rule interpretations and provide guidance in order to make independent and sound decisions
Some Regulatory knowledge preferred
Some knowledge of wireless communications preferred
Good team, interpersonal and organizational skills
Ability to prioritize and manage multiple tasks
Ability to demonstrate strong research and analytical skills

Product Safety & Regulatory Specialist Resume Examples & Samples

Responsible for addressing issues escalated concerning Product Safety communication, classification and regulatory compliance. To carry out in depth impact analysis. To communicate impacts to relevant business departments and functions and recommend appropriate preventive or corrective actions
To develop and maintain product safety communications processes and procedures in particular for Safety Data Sheets, Classification and Labeling, and commercial product introduction. Communicate with businesses and ensure link with business processes as appropriate
To provide support on interpretation of content of safety data sheets including of extended safety data sheets
Responsible for approval of Pigments Environmental, Health and Safety aspects of product labelling sector
To carry out and lead technical work and integrity of data necessary to ensure the compilation and availability of compliant safety data sheets and labels for new and existing Huntsman products for the region
Act as first point of contact with all businesses commercial and product management departments to initiate processes for commercial product introduction, commercial product extension and market extension
To coordinate data entry in SAP EHS with Systems and data management team
To approve and quality control all safety data sheets and labels for classification, content and lay out
To support functional team's network and special projects from businesses departments on commercial product introduction, commercial product extension and market extension
To provide training to commercial and product management departments
To liaise with and support other Pigments Environmental, Health and Safety functions
Participates in and completes company-required training programs
Participates in Environmental, Health and Safety initiatives as set forth by the company
A minimum of a Graduate Chemist with 10+ years specific in depth experience, particularly in NAFTA region
Technical skills and knowledge of chemistry sufficient to: 1) Understand Pigment business production process, 2) Understand the potential risks associated with product applications and handling, 3) Compile critical data required for Safety Data Sheets and other technical literature, and 4) Allow the organization of appropriate product use testing must obtain extensive knowledge of Pigment business activities at all the operating sites
In-depth knowledge of EHS legislation and principles
In-depth knowledge of Product EHS legislation and principles

Wireless Regulatory Specialist Resume Examples & Samples

Perform regulatory screening on all NJ Projects and advise team on scope required to get approval, i.e. minor/mod, full filing, and section 106 review
Proactively interface and drive behavior from external & internal teams involved in the regulatory process so that approvals are obtained on a timely basis
Regulatory SME/Liaison for the region, with regular interface with NE Regulatory team and the current FCC/VZW mandates
Expertise in all NEPA/FAA/ASR policies, with the ability to navigate and realize approvals through the most efficient channels
Issuance of Smart Forms to determine regulatory requirements
Interface with ERM to process sites that need section 106 screening and review
Phase 1 and Phase 2 ordering and management
Routing of appropriate approvals (EES, ES)
Coordination of NTC/BMDS
Coordinate & communicate regulatory approval status via Siterra and Site Tracker
Complete any environmental work required for lease amendments
Excellent communication and teamwork abilities
Project Management background required, with the ability to organize and track complex processes
Proficient in Microsoft Office & other project tracking tools, and ability to create and utilize reporting mechanisms

Field Regulatory Specialist Resume Examples & Samples

Represent Hess – establish and maintain relationships of integrity and trust with all Regulatory agencies
Coordinate, schedule, and perform required inspection and testing including but not limited to quarterly AVO air surveillance, semiannual OGI, and quarterly SPCC inspections
Follow up on corrective actions to verify implementation and compliance
Provide technical assistance, regulatory oversight, and coaching as needed
Provide training to operation field personnel for state and federal regulatory requirements
Collaborate with Operations to ensure development of SOPs for compliant operation of equipment
Facilitate discussion of field observations and program improvements at daily Operations meeting
Entry of SAP notifications as needed
Specific knowledge of Regulatory requirements and practices including but not limited to NDIC, ND DoH, BLM, EPA
Understand and comply with all EHS policies and procedures
Ability to communicate clearly and concisely both orally and in writing
Highly motivated self-starter with ability to work independently
Ability to supervise and influence 3rd party contractors
Ability to lead and direct others to ensure regulatory compliance within field operations
College degree or relevant experience
Minimum 2 years of experience in regulatory compliance experience – preferably in North Dakota
Extensive knowledge of oil and gas field operations

Wireless Regulatory Specialist Resume Examples & Samples

Coordinate FCC/FAA/NEPA/SHPO Filings to HQ Regulatory team. Work with RF Design, Construction, and Real Estate teams to ensure new sites and modifications are in compliance with corporate guidelines. Ensure compliance with all Regulatory guidelines for all assigned Projects by following established procedures and maintain awareness of all applicable changes
Coordinate, review and project manage Environmental Due Diligence required to complete Lease packages and prepare Cell Sites for Construction
Maintain open and ongoing communications with the internal and external Teams assigned to the specific projects, including, but not limited to Site Acquisition Consultants, RF Design, Regulatory, System Performance, Operations, Regional Attorneys, Engineering Firms and Professional Expert Consultants
Track and manage the regulatory filing process. Provide regular reports on status. Enter required information into HQ databases applicable to the Cell Build and Embedded Base Programs, including Siterra, SiteTraker, EMIS, & XNG so as to ensure accuracy
Review vendor invoices applicable to assigned Search Areas and forward on to Real Estate Manager for approval
Maintain and manage the capital spending for all assigned Projects. Ensure that the capital spending for all assigned Projects is within the budget previously forecasted and be able to provide regular reports on current spending trends, as well as projected spending
Work closely with HQ Real Estate Team to be aware of the acceptable legal language, and its approved modifications, for any and all Lease Agreements and Amendments
Enter any and all applicable information into Network databases and into monthly HQ Reports
Bachelor of Science degree in Engineering, Business Administration or equivalent experience
Two or more years of relevant experience
Current knowledge of and familiarity with state and local land use and zoning procedures
Experience with known Wireless Industry vendors/tower companies, i.e., Crown Castle, American Tower, SBA, AT&T, Sprint, T-Mobile, etc
Strong presentation, written and oral skills needed in order to successfully interface with legal, environmental, and regulatory vendors as well as municipal authorities
Strong problem solving, communication and interpersonal skills
Must have superior Project Management skills; work quickly, accurately and effectively in a highly fast-paced, demanding environment, with aggressive goals. Must be able prioritize tasks and manage multiple projects
Ability to work under extremely tight deadlines and manage competing priorities. General familiarity with RF Design standards
Team player attitude is a MUST
Proficient in Microsoft Word and Excel, PeopleSoft knowledge a plus
Ability to manage multiple professionals, including but not limited to, Attorneys, Zoning Team members, Engineers and outside Consultants
Valid Driver’s License required

Product Regulatory Specialist Resume Examples & Samples

Responsible for contributing to regional compliance in the region including substance registration and providing timely communication to business and impact analysis of new and draft regulation
Monitor application specific regulatory requirements and perform registrations (eg. food contact, cosmetic regulation, plant protection, TSCA, PMN, FIFRA, DSL, CDR reporting, etc.)
Monitor and interpret (existing and developing) legislation and assess impact on business in order to provide advice in a proactive and timely manner
Represent AkzoNobel in industry associations and consortia
Support business by responding to customer enquires related to regulatory such as inventory status, food contact status, eco labelling etc
Responsible for performing compliance checks on a regional (global) level and providing compliance documentation to support business needs
Direct support to strategic customers upon request from business such as provides training to customer, attend business meeting, meet strategic customer
PSRA review of new products and changes of products in the region and also support global launching of new products
Prepare all necessary PSRA information/documentation for the launch of a new or changed product or import of new product to the region and sign off in Product introduction systems (NUSAP, PDP or P,I&C)
Lead or participate in complex projects within the PSRA area, like global launching of new product
Responsible for facilitating registration / notification processes on a regional (global) level
Responsible for following the AkzoNobel Business Principles and Code of Conduct with an obligation to report deviations in legal compliance to responsible manager
Strives to identify improvements and implement them
Responsible for (initiating and) setting up harmonized processes within own area of responsibility in the Business Area concerning business processes and change management
Obligation to maintain / archive product data, documents, decisions and assessments in accordance to legislation and other internal requirements
Develop product regulatory information in files or in databases
Develop a strong working relationship with business
Develop a strong working relationship with global team members, driving success with personal development, and strong understanding of how to win together
Master of Science in Chemistry or Chemical Engineering or related field and minimum of 4 years of relevant experience or Bachelor of Science in Chemistry or Chemical Engineering or related field and minimum of 10 years of relevant experience
Broad background in chemical regulations, hazard communication and product stewardship
Good skills in Microsoft Office Applications and in SAP/EHS
Excellent communication skills and very good in English
Acts pro-actively with integrity
Has hold a job as project member or led a functional project within the own unit

Clinical Trials Regulatory Specialist Resume Examples & Samples

Excellent communication skills and superb attention to detail
Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB
Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice

Capital Markets Operations Regulatory Specialist Resume Examples & Samples

Knowledge of Microsoft Office products with advanced Excel skills
Effective time management skills and ability to work in a dynamically changing environment with multiple deadlines
Enthusiasm and commitment to a team based working environment
Knowledge of financial regulatory requirements a plus (CFTC, ESMA, FINRA, MSRB, SEC)

Clinical Trials Regulatory Specialist Resume Examples & Samples

Preparing and submitting IND applications and amendments
Registering and reporting results for clinical studies at ClinicalTrials.gov
Developing and delivering training
Developing and deploying new regulatory processes
Supervising and managing others
Functional knowledge of regulatory affairs including FDA regulations, IRB review and approval process and Good Clinical Practice
MS Office and database applications
Interpersonal and customer service skills
Demonstrated ability to manage multiple projects and/or staff under varying time constraints

Compliance & Regulatory Specialist Resume Examples & Samples

Review and approve Trackwise PRs as needed acting as a QA Representative
Act as Compliance Coordination for FDA, ICH, MHRA, EMEA guidelines and like documents ensuring that new information is disseminated and employees are aware of new guidances to ensure that site stays current with compliance regulations
Support customer, internal, corporate and regulatory audits as required
Support Site investigations representing QA
Close Trackwise PRs as QA representative as assigned
Develop/revise QA/Regulatory/ Compliance procedures and revise existing procedures as required
Support compliance work load on an as needed basis such as authoring DMFs, SMFs, APRs and other regulatory documents as assigned
Support QA Special Projects /activities as assigned
Represent QA on project teams, management meetings, and other internal forums
Contribute to process (LSS) improvement initiatives
Interdepartmental communication for obtaining information
Comply with an ensure compliance of the department with Health, Safety and Environmental responsibilities
Zero to three years of experience working in the pharmaceutical industry
Understanding of FDA cGMPs and DEA regulations pertaining to Pharmaceutical Development
Good computer skills, including in depth knowledge of Word and spread sheet software
Safety procedures associated with the department
Understand procedures related to document control, Quality Assurance and this job function
Candidate must have the ability to work effectively under high pressure with multiple project deadlines
Candidate must be detailed oriented with effective oral and written communication skills, team oriented with effective interpersonal skills. Candidate must be responsive to timelines and adjust priorities as required
Candidate must have computer skills with MS Office

Regulatory Specialist Resume Examples & Samples

A minimum of a Bachelor’s Degree in Engineering, Technical Science, or related field is required
A minimum of 4+ years of experience in a medical device and/or pharmaceutical industry, including 1+ year within a regulatory and/or compliance role is required
Experience with field action related activities is preferred
Working knowledge of 21 CFR Part 820, QSR, ISO 13485, CFR 806, and MDD/IVDD requirements is preferred
Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc. is preferred
Excellent computer skills (e.g., PowerPoint, WORD, Excel, Visio) is required

Environmental Regulatory Specialist, Junior Resume Examples & Samples

6+ months of experience with transportation, hazardous materials management, environmental, or customer service work, including internships or volunteer work
Ability to show coursework in hazardous materials management, transportation, environmental science, policy chemistry, engineering, or biology
BA or BS degree required
Experience with databases or other information management systems
Ability to learn complex information
Ability to show fluency in Spanish

Network Engineering Environmental Regulatory Specialist Resume Examples & Samples

This role will be responsible for environmental and regulatory compliance for the network engineering team
Work with HQ, RF Design, Construction, and Real Estate teams to ensure new sites and modifications are in compliance with corporate guidelines
Coordinate any NEPA/SHPO Filings with HQ Regulatory team and submit documents (ES, ERF, EES, NTC, P2 SOW, etc.)
Order Section 106 & NEPA Reports
Review SAELs, Phase 1s, & Phase 2s and request extensions as necessary
Circulate and process EES/NTC for local approvals
Provide feedback to SACQ’s for preparation of ERF, EES, NTC
Review & approve LEs, CDs, ZDs
Enter required information into HQ/Regional databases, including Siterra, SiteTraker, NetSites, EMIS, etc
Interface directly with the environmental vendors and provide support as necessary
Review and process applicable vendor invoices
A Bachelor’s of Science degree in Engineering or equivalent experience
Two or more years of relevant experience in the wireless cell site environmental regulatory process

Food Safety, Quality & Regulatory Specialist Resume Examples & Samples

35% In-depth management of specific segments of quality management systems (i.e. food safety, data systems – SAP management and setup, and/or other quality systems, etc.), providing support for operations or other functional areas where needed
30% Process monitoring, system improvement support, specialized testing, training, plant trials, enterprise and local execution of best practice initiatives, and auditing of systems and performance
25% Customer/Supplier/Warehouse interaction, response to issues (plant/external warehouse), review of supplier documentation, updates to raw material internal specifications, new product/revised product set-ups in SAP (including management of change processes and certification requests)
10% Miscellaneous job related duties i.e. facility audits/team involvement, quality instrumentation, food safety items for the pilot plant, operations/FSQR Manager support
Minimum 3 years of Food Safety, Quality and Regulatory experience
Demonstrated technical and leadership skills
Ability to effectively communicate with diverse groups of people with varying levels of education
Ability to balance and achieve positive results in the areas of food safety, safety, quality, productivity, and cost

Clinical Trials Regulatory Specialist Resume Examples & Samples

Experience submitting regulatory documents to the NCI CIRB, or other central Institutional Review Board
Ability to multi-task, manage, and report on up to 5 new studies and/or 7 amendments/revisions at one time
Knowledge of oncology and clinical research conduct desired
Certification through a professional organization such as Regulatory Affairs Professional Society (RAPS) or The Society of Clinical Research Associates (SOCRA) preferred
Certification through a professional organization such as RAPS or SOCRA preferred

Senior Regulatory Specialist Resume Examples & Samples

Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies)
Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects
Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate
Serve as Novella liaison with central IRBs
Perform other related duties as assigned
Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international
Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking
Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards
Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems
Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports
Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
Ability to read and synthesize technical material and to prepare clear and concise written documents
Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance

Regulatory Specialist Resume Examples & Samples

Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies)
Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects
Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate
Serve as Novella liaison with central IRBs
Perform other related duties as assigned
Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international
Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking
Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards
Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems
Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports
Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
Ability to read and synthesize technical material and to prepare clear and concise written documents
Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance

Product Regulatory Specialist to Akzonobel Stenungsund Resume Examples & Samples

Responsible for the Regulatory Regional mailbox where internal and external customers send their requests
Coordinate, answer and archive internal and external customer questions in the region
Responsible for product registrations to national authorities, for example to poison centers
Maintain and develop databases containing product regulatory information
Participate in PSRA projects
Bachelor in chemistry/chemical engineering and minimum 6 years’ experience from relevant field or Master in chemistry/chemical engineering
Basic knowledge of chemical regulations
Ability to take on responsibility and make decisions balancing business orientation and legal requirements
LI-PH

Customer Quality Regulatory Specialist Resume Examples & Samples

Ability to work in a cross-functional matrix environment
Active listening/ phone skills
Collaboration and teaming skills
Critical thinking skills
Prioritization and multi-tasking skills
Knowledge of basic medical terminology
Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint)
Continuous learner
Global mindset
Accountability for own work
Problem solving/Root cause analysis skills

Wireless Regulatory Specialist Resume Examples & Samples

Analyze Shielding requests from the submarkets utilizing Airspace (TERPS) and Google Earth to determine if site qualifies for shielding therefore not requiring an FAA approval
Prepare and submit applications to the FCC's Universal Licensing System (ULS), FAA OEAAA systems and the Departments of Transportation (DOT) when required. Filings would include the following: FAA determination, FCC Antenna Structure Registraton (ASR) and Environmental Assessments (EA) on an ASR or on one of the various licenses
Monitoring of EAs for grant and retrieval of Fonsi's to ensure compliance
Monitoring of ASR application returns and address the FCC's concerns in a timely manner to ensure grants are obtained and network buildplan is not negatively impacted
Preparation and keying of licensed applications being submitted to the FCC
Acceptance and processing of IS Notifications for cellular sites and microwave paths/frequencies to determine if further filings with the FCC are required. If so, prepare and submit applications as needed
Prepare and respond to Status Requests from the FAA
Develop regulatory training programs such as on-ste workshops, on-line training tools and web meetings regarding FCC rule interpretations and regulatory policies and procedures
Develop and implement processes for regulatory and engineering strategies to expedite service while ensuring compliance with governing rules
Participate in training as needed to gain a better understanding of rules and internal procedures
Analyze, interpret and apply the principles of the FAA regulations and corresponding FCC rules (Code of Federal Regulations (CFR) Part 17) regarding obstacle evaluation, including identification of heights exceeding minimum instrument flight altitudes, heights exceeding conical surfaces for prescribed slope calculations and obstruction and marking/lighting requirements, including painting guidelines, lighting guidelines and acceptable configurations
Analyze, interpret and apply the principles of the FCC rules (CFR Parts 1, 22, 24, 27 & 101) for all services (700 MHz, AWS, Cellular, PCS & Microwave). This would include disturbance of AM broadcast station patters, frequency tolerance, field strength agreement, Effective Radiated Power (ERP) manipulation, international border requirements, Quiet Zones, Height Above Average Terrain (HAAT), bandwidth, power, antenna height limits, including ability to understand the technical content of microwave applications (azimuth, antenna gains, stability, power measurements, digital modulation rates, modulation types, and frequencies transmitted), paired and unpaired frequencies
Analyze and monitor regulatory information submitted by submarkets in preparation of federal, state and local applications and reports to obtain FAA approvals, FCC grants and state DOT approvals when required
Analyze, interpret and make decisions relevant to engineering, technical and regulatory information in order to (a) ensure FCC compliance for all Verizon sites and licenses (700 MHz, AWS, Cellular, Microwave & PCS) through extensive use of various systems such as ULS, VZReg, Siterra and MapInfo; (b) assess the potential broad impact of regulatory filings; and (c) recommend best business practices, including changes in regulatory policies and procedures
Develop, implement and maintain automated mapping functions and processes such as: (a) nationwide maps per service; and (b) monitoring of competitor cellular (850) applications and the possible impact to Verizon licenses
Responsible for monitoring of both of the departmental mailboxes (Licensing Compliance and Network Regulatory) to ensure that everything is handled in a timely manner
Notice of Proposed Rulemaking (NPRM) interpretation - interpret proposed federal rules and their potential impact to the departmental policies and procedures and communicate these interpretations and impact to management as needed
Understand the engineering required in order to create and modify depictions of market boundaries including unlicensed area, Service Area Boundary (SAB) and Cellular Geographical Service Area (CGSA) utilizing MapInfo
Establish and maintain open communications with submarket employees and various governmental agencies including regular interaction with management
Act a team lead while providing guidance on various projects
Recognize and identify business risks and use sound judgement to provide creative solutions to other staff members and to submarkets
Research FCC site and/or path/frequency buildouts to ensure that they are met
Active license validation for microwave licenses prior to preparing and submitting renewal applications to the FCC

Principal Regulatory Specialist Resume Examples & Samples

BA or BS degree (degree in a technical discipline highly preferred)
Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
Experience with submissions related to Software
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Multitasks, prioritizes and meets deadlines in timely manner
Ability to travel approximately 5%, including internationally
Ability to maintain regular and predictable attendance
Ability to identify and solve problems in a strategic manner
Ability to manage complex projects
Ability to be proactive and not reactive, to anticipate changing business and regulatory environments

Technical Regulatory Specialist Resume Examples & Samples

BS degree in Agronomy, Biology, Chemistry, Entomology or a Related Lawn and Garden Field
3-5 Years experience in regulatory affairs, EPA pesticide products and/or fertilizer products
Knowledge of EPA pesticide registration procedures and fertilizer registration procedures in the states
Knowledge of procedures for organic product certifying agencies such as OMRI and California Organic Input Material program
Able to multi task under stressful situations, able to work in a fast paced, deadline driven environment
Independent, self-starter; able to work with minimal direction
Ability to work in a collaborative, team based organization, with strong relationship skills; able to work well with other functional areas
Strong analytical, organizational, written, and verbal communication skills
Proficiency in the use of Microsoft Office applications and SAP

Business Risk Regulatory Specialist Resume Examples & Samples

Regulatory & Compliance
Standards & Policies
Outsourcing, Nearshoring & Offshoring and Vendor management

Assistant Environmental Regulatory Specialist Resume Examples & Samples

Revise and maintain applicable EPA Compliance Programs’ implementing procedures and desktop instructions
Support the preparation of an electronic interactive version of the 2019 Compliance Recertification Application
Collaboratively interact with technical authors and editors to produce regulatory documents and resolve comments
Assist with the management of two electronic libraries that include the posting of compliance documentation plus past, present and future compliance applications to the EPA as required by 40 CFR 194
Collect data using advanced Geospatial Information System techniques, process and enter data in a database as part of the Delaware Basin Drilling Surveillance Program
Assist in the writing of periodic program reports
Produce maps using the above data via ESRI ArcGIS
Familiarity with the WIPP Project a plus

Clinical Trials Regulatory Specialist Resume Examples & Samples

Compliance: Support & comply w/the Principles of Responsibility (KP Code of Conduct)
W/guidance from PI & KPSC Clinical Trials Compliance Dir, assist w/ensuring compliance w/KPSC IRB Standard Operating Procedures (SOP) & document applications
Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures
Assure all site documents including SOPs & administrative files are maintained in audit-ready condition
Assist w/internal & external audits & quality assurance activities including monitoring visits, audits & inspections
Support the cost effective financial aspects of the clinical trial
Study Implementation: Prepare the following IRB documents: a. new protocol applications; b. KP consent form draft; c. Protocol modification forms; d. Adverse Event/Serious Adverse Event summary for annual report; & e. IND Safety Report Summary sheet for annual report
Assist the PI & other designated research staff in the preparation, submission, & maintenance of the following study-related regulatory documents: a. Current & obsolete versions of protocol & consent forms; b. FDA form 1572 &/or 1571; c. Protocol violations/deviations; d. Serious adverse events; e. Current & obsolete Investigation Drug Brochures; f. Documentation of IRB submissions & related correspondence, reports, & letters; g. Current laboratory certifications & normal reference ranges; h. Research staff CVs & licenses, training materials, & certifications; & i. Test article accountability forms, signature logs, etc
W/direction from PI, assist in preparation of annual, interim & final KPSC IRB reports
Maintain training & education documentation for research personnel
W/direction from PI, communicate & coordinate w/the Sponsor regarding study document regulatory file on activities & functions, including scheduling & conducting Sponsor-initiated monitor visits & following-up on outstanding items
Coordinate w/the PI & internal/external parties regarding the collection & maintenance of regulatory IRB & other documentation & procedures
Perform data entry of study activities into a database program to track pertinent study activity (i.e., study enrollment, consents, protocol violations/deviations, serious adverse event reports, & IRB history)
Maintain all study-related legal & financial documents in separate confidential regulatory file in a timely manner, as requested
This job description is not all encompassing
Minimum three (3) years of effective project management experience in clinical trials research or human subject's protections required
Bachelor's degree may be substituted for one (1) year work experience
RAC certification will be considered
CIP, CIM, ACRP or SOCRA certification preferred

Associate Regulatory Specialist Resume Examples & Samples

Legal evaluation of the company products for the intended industry
Responsible for the creation, issuance and updating of product documentation which could include documents such as specifications, allergens, GMO, labeling, country compliance, kosher, halal, SDS, nutritional information, country of origin and other Regulatory documentation to customers and technical personnel as needed
Vendor communication, interpretation of vendor documents and maintenance of raw material database
AAFCO compliance and natural reviews
USDA label sketch approvals – responsible for creating and submitting to the agency for approval
TTB submissions for flavors and drawback
Communicate with external governing agencies and trade associations as required
Evaluates formula revisions and communicates labeling modifications to customers
Complies with the food safety management system and participates as required to ensure food safety and ISO/Food Safety certification
Perform other duties and special assignments as required

Regulatory Specialist Resume Examples & Samples

BS food science, chemistry, biology or related technical field or 4 years of experience (education & work combined)
Prefer - Citrus and /or plant based product(s) experience
Demonstrated ability as a self-starter
Demonstrated ability to communicate effectively (written and verbal) with a variety of internal and external contacts
Strong PC skills using Microsoft Office Suite
Demonstrated ability to prioritize workload and handle multiple tasks and projects simultaneously in an effective manner
Attention to detail is essential. Must be conscientious, accurate, organized and a team player. Position requires adaptability to changing priorities and adeptness at meeting deadlines
Knowledge and understanding of food composition and chemistry is required. Ability to judge the applicability of technical information from unrelated sources to issues specific to Kerry Inc. products and raw materials

Real Estate Regulatory Specialist Resume Examples & Samples

An Associate's degree in related field or equivalent experience. Even better if you have your Bachelor’s degree
Two or more years of experience working with Tower Companies, DAS providers, site acquisition companies and negotiating contracts
Two or more years of experience working on small cells, ODAS, and other similar projects
Two or more years of experience with network real estate processes and issues specific to large scale & volume projects as well as similar experience in external facing projects and negotiations
Two or more years of experience in managing complex projects worth more than $1M
Understanding of various wireless network technologies including switching, RF, transport and data
Proven ability to originate, analyze, negotiate, structure, prepare, and present master agreements involving risk analysis
Prior leadership experience in a dynamic team environment
Advanced knowledge of land use, right of way, and zoning policies and procedures
Thorough understanding of real estate practices/law, business and financial terms/concepts
Strong negotiation, presentation, and written skills required in order to effectively deal with governmental authorities, REIT’s, and realize competitive lease rates with property/asset owners
Proven ability to manage and execute multiple tasks and multiple projects simultaneously
Demonstrate ability to manage external professionals (site acquisition professionals, architects, engineers, land planners, attorneys other consultants) toward fulfillment of common network goals
Knowledge of FCC and FAA regulations
CA real estate sales license or broker’s license required

Medical Affairs / Regulatory Specialist Resume Examples & Samples

Ensuring that processes for local product packages are in place and the packs are prepared on time, in line with company and local requirements
Cooperating with local management and marketing, proposing and agreeing on local registration strategy and local registration priorities
Developing understanding of regional regulatory environment, competitor intelligence and therapeutic area
Maintaining of up-to-date record of registration laws, requirements and procedures for registration, re-registration and changes
Ensuring that product licenses are maintained and ensure that re-registrations are prepared and performed in timely manner
Ensuring that product information (used in labeling, datasheets and promotion) is the most recent and in accordance with Company Core Data Sheet and local requirements

Chemical Regulatory Specialist Resume Examples & Samples

Perform timely and accurate hazard assessments for new and modified products to assure compliance with domestic and international safety regulations. Maintain product safety information in appropriate databases to meet routine and growing business needs
Review and approve new and modified product labels for product safety content and compliance to international labeling standards to meet production and regulatory needs. Implement methods to assure that product safety data is accurate and up to date, and processes for product safety information management are effective and efficient
Coordinate the work of external contract safety testing groups as directed to assess and classify potentially hazardous materials, products, and instrumentation
Assist in global product safety compliance activities required in the development of new products. Serve as corporate liaison for regulatory agencies and corporate partners related to product safety. Proactively seek information on global regulatory trends or changes in product safety and hazard communications that might affect Promega’s business operations
Provide technical support and direction to scientists and teams for all project/program efforts related to product safety and product shipping and distribution
Maintain methods for creating and deploying product safety information and documentation (MSDS’s, labels, shipping information, scrap instructions) and maintenance. Maintain records as necessary to comply with business and regulatory requirements
Assist in the global MSDS distribution and posting methods to ensure that accurate and compliant information is sent to branches, distributors and end users
Participate in the planning and execution of internal audits as directed to assess the effectiveness and efficiencies of compliance practices and their support processes
Develop, maintain and assist in the development of safety programs. Train Promega employees in these programs; hazard communication, personal protective equipment and chemical hygiene, for example
Participate in the design, execution, and documentation of quality system software and process validations as directed
Contribute to the proactive design, implementation, and improvement of all compliance processes supported by the department
Understands and complies with ethical, legal and regulatory requirements applicable to our business
Represent the interests of the company in industry or professional organizations tasked with establishing consumer product safety regulations or guidance
Lead or contribute to product safety software improvement, upgrades or installation projects
Requires an Associate Degree in Occupational Safety/Industrial Hygiene, physical sciences, or life sciences discipline
Demonstrated experience (1-3 years) performing product safety assessments using product safety software and web publishing systems
Intermediate level understanding of general lab practices chemical based lab products
Experience in labeling and shipping of hazardous products
Must be able to work with minimal direction. Strong attention to detail and sound ability to interpret, translate and address regulatory needs
Experience in various software and database applications to enhance individual productivity
Strong oral and written communication skills. Demonstrated ability to read, understand and assist others in developing means to comply with regulations while meeting business needs
BA/BS degree in Occupational Safety/Industrial Hygiene and/or BS/MS in Chemistry with product safety experience. Candidates with strong chemistry background and experience are preferred
Greater than 5 years’ experience in hazardous product evaluations, global product safety programs, or product safety management
Must be highly self-motivated, organized, and an individual requiring limited supervision/guidance. Successful candidate will be able to facilitate employee- and customer-friendly business solutions involving product safety issues
Experience in selecting, implementing, maintaining and improving product safety software would be helpful
Ability to move boxes weighing up to 30 lbs
Ability to use PPE as necessary to perform assigned tasks

Technical Regulatory Specialist, TTB Resume Examples & Samples

Requires a minimum of a Bachelors of Science in Chemistry, Biology, or related field plus 3-5 years’ work experience in a customer-oriented environment in Flavors, food or chemical manufacturing industries. Requires knowledge of FDA, USDA, TTB, and Harmonized Tariff Codes
Must have proficient computer skills including the use of Microsoft Office and ability to learn the DevEx regulatory software. Strong organizational and math skills and the ability to work effectively in a team as well as independently are mandatory. This position will also require reading of technical documents and having the ability to understand and interpret them
Additionally, the position requires an up-to-date understanding of regulatory requirements, including US federal and state governmental regulations, as well as the ability to research and access international regulations and contemporary industry topics, as required. Candidate must possess the ability to learn the customer specific requirements that pertain to Sensient products

Clinical Regulatory Specialist Resume Examples & Samples

To be considered for the role a minimum of a Bachelor’s Degree in Nursing, Life Sciences or Health Sciences is required
A minimum of 2 years of professional experience is required
A minimum of 1 year in a medical device and/or pharmaceutical industry is required
A current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is strongly preferred
RAC or ASQ certifications are preferred
Experience in regulatory affairs, post market regulatory, quality or compliance areas is preferred
Working knowledge of 21 CFR Part 820, QSR, ISO 13485, CFR 806, and MDD/IVDD requirements is preferred
Experience with health authority reporting preferred
The ability to work independently and prioritize with little supervision is required
Strong written and oral communication and interpersonal (listening) skills is required
The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required
Analytical and critical thinking skills are required
Excellent organizational and time management skills are required
Strict attention to detail is required
The ability to work autonomously and on multiple projects with accelerated timelines is required
Proven ability to meet timelines is required
Excellent computer (e.g., PowerPoint, WORD, Excel, Visio), communication, and written skills are required
This position will be based in West Chester, PA and will require up to 10% travel, including potential international

Senior Technical Regulatory Specialist Resume Examples & Samples

BS degree minimum required, preferably MS or PhD in biological sciences or chemistry
5 Years employment in a regulated product industry (preferably EPA or FDA) Knowledge of pesticide registration process is preferable
Excellent oral, written, and organizational skills required
Must be both detail and team oriented
Strong computer skills required; must be proficient in MS Office applications
Experience with SAP is a plus
Ability to work in a constant state of alertness and safe manner

Associate Regulatory Specialist Resume Examples & Samples

Authoring safety data sheets (SDS) for Ecolab business units
Providing input for product labeling
Address hazard communication-related questions
Become familiar with the Globally Harmonized System for Classification and Labelling of Chemicals (GHS)
Become familiar with regulations applicable to specific areas of responsibility (e.g., Occupational Safety and Health Administration Hazard Communication Standard, California Proposition 65)
Conduct substance- and raw material-level hazard characterizations
Develop materials and participate in activities with Ecolab customers
Data entry and system maintenance for an electronic SDS authoring system
Providing guidance on prospective classifications for experimental products
Participate in internal Ecolab research- and business-related meetings
Bachelor’s degree, preferably in a technical field
0-3 years of professional experience
No Immigration Sponsorship available for this role
Ability to learn business and regulatory processes
Ability to read and interpret technical and regulatory documents
Good data management skills, including attention to detail
Prior experience with Safety Data Sheet authoring
Knowledge of Hazard Communication regulations and guidelines
Experience with SAP software

Regulatory Specialist Resume Examples & Samples

Assist Regulatory Affairs Manager and Director of Regulatory Affairs in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance’s issued by the applicable regulatory agency(ies)
Support regulatory documentation review related to the compilation and maintenance of project specific master files as required for regulatory compliance for assigned clinical research projects
Serve as Novella liaison with central Ethic Committees and competent authorities as delegated by Novella Sponsors
Review all essential regulatory documentation both for Green light release and on-going throughout the life cycle of the study
Support project teams with review of essential documents and country regulatory documentations are audit ready at all times

Product Stewardship & Regulatory Specialist Resume Examples & Samples

Manage safety data sheets (SDS) and hazard labels for products and samples including
Ability to interpret guidelines, regulations and legislation applicable to DuPont products, safety data sheets (SDS) and product labeling requirements
Knowledge of current regulations impacting SDS requirements worldwide: REACH, CLP, GHS, etc
Ability to understand technical and regulatory areas pertaining to Industrial Biosciences products and general R&D scientific methods
Excellent planning, organizational and communication skills
Ability to stay focused working in independent working environment
Experience working for a global organization in a multicultural environment is preferred
Knowledge of SDS software (e.g. The Wercs, SAP):desirable
Competency in computer/software tools
Bachelor’s degree in science field

Principal Regulatory Specialist Resume Examples & Samples

Readily shares knowledge and expertise with other, mentors others on technical and regulatory strategy issues
Builds bridges with team members inside and outside of the regulatory team
Adjust personal style to deal effectively in differing situations with various types of people
Effectively challenges others’ ideas or opinions without creating hostility
Tactfully diffuses tense situations
Solicits and utilizes input from internal and external resources to help guide project teams
BA or BS degree (degree in a technical discipline preferred)
Strong Excel and reporting metrics experience
Minimum 6 years’ experience; 8 years preferred in a highly technical environment
Familiarity and exposure to regulatory affairs
Ability to collaborate and work cross functionally
Ability to present complex data adapted to the targeted audience
Strategic mindset and ability to perform gap assessments and implement process improvements
Ability to develop, implement and maintain performance metrics for multiple areas within regulatory
Ability to manage complex projects as well as the ability to leverage and/or engage others to accomplish projects
Minimum of 3 years’ experience in regulatory affairs or other regulated environment
Experience with medical device industry preferred
Be able to handle multiple projects and daily tasks
Partner with regulatory peers to address gaps and provide process solutions
Understand decision risks and be able to make recommendations with little information or direction

Human Health Regulatory Specialist Resume Examples & Samples

Developing food safety and regulatory support business for clients working with Chinese regulations and regulators
Developing Exponents’ capability to support import tolerance applications to ICAMA and other emerging Asian programmes
Provide strategic guidance and advice to clients on meeting regulatory requirements in the area of residues consumer safety in Europe
Provide high-level verbal and/or written inputs to project teams, contributing to the achievement of best possible decision-making and highest-quality outputs
Perform data-gap analyses and provide project advice to clients. This can involve the design and monitoring of packages of experimental studies
Apply knowledge and experience to interpret data from suites of studies, drawing sound scientific and regulatory conclusions
Generate high-quality submission documents, including summaries of individual study reports, summaries of data sets, consumer risk assessment calculations and overall conclusions
Project management ensuring that projects are delivered to high standards, on time and within agreed budget
Building network of local in-country experts
Developing and leading a successful team
An MSc or PhD in chemistry, biology or closely related field
High level of technical and regulatory expertise
A proven track record of successful regulatory submissions
Excellent written and communications skills
Experience of effective staff management and team development
Proven experience of business development

Principal Regulatory Specialist Resume Examples & Samples

Master’s in Business Administration
Pharmaceutical cGMP-related and product approval experience
Global biocide regulatory experience
Experience working directly with R&D, operations, supply chain, marketing and legal departments to support product and service commercialization

Senior Clinical Regulatory Specialist Resume Examples & Samples

Candidate must be comfortable reporting to a manager located at a different facility; due to this structure, candidate must be an independent professional who proactively communicates frequently and effectively
Must be comfortable working on projects where the project and its team members may be located at other sites
Should be at ease with direct communication with internal project team members, external CROs and Pharmaceutical partners
Should be organized and able to work to on multiple projects with tight deadlines
Willing to travel away from home on an occasional basis
High energy level; positive attitude; works well under stress; assertive and effective communicator
Hands-on, action-oriented, and able to implement effectively
Minimum of 4 years working in the In Vitro Diagnostic (IVD) or Medical Device Industry. In Vitro diagnostic experience is a plus
A Minimum of 4 years demonstrated experience managing in house and/or external clinical studies
Experience working with multi-functional project teams is required
Computer literacy, including spreadsheet, database and word processing applications required

Research Regulatory Specialist Resume Examples & Samples

Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures as well as other regulatory policies and procedures regarding human subject research
Submits serious adverse events, IND reports, protocol addenda and/or other documents to Institutional Review Boards by (1) accessing multiple websites (COG, ECOG-Acrin, SWOG, NRG Oncology, CTSU, etc.) on a routine basis to obtain protocol-specific updates (2) reviewing addenda to determine appropriate reporting requirements and reporting timeframes (3) independently and accurately preparing IRB submission packets including changes to informed consent documents (4) reviewing submission packets with Principal Investigators, Clinical Research Coordinators, Clinical Research Assistants and/or sponsors for accuracy (5) tracking packets from initial submission to Institutional Review Boards to receipt of final approval documents (6) performing a quality assurance review of approved documents to detect inaccuracies (7) entering updated approval dates in database (8) filing approval documents in regulatory and/or study binders (9) distributing new documents to patient care units and (10) alerting Clinical Research Coordinators and ancillary staff of new documents
Prepares Institutional Review Board continuing review reports by (1) independently and accurately completing continuing review/study closure report forms and attaching supporting documentation such as cumulative adverse event tables, de-identified signed informed consent documents, data safety monitoring board reports and/or audit reports (2) reviewing documents with Principal Investigators, Registered Nurse Specialists, and/or Program Assistants for accuracy (3) submitting documents to Institutional Review Boards within appropriate timelines in order to prevent project expiration or sponsor deficiencies (4) tracking packet from initial submission to Institutional Review Boards to receipt of final approved documents (5) performing a quality assurance review of approved documents to detect inaccuracies (6) entering updated approval dates in database (7) filing approval documents in regulatory and/or study binders (8) distributing new documents to patient care units and the Clinical Trials Support Unit and (9) alerting Clinical Research Coordinators and ancillary staff of new documents
Submits new projects to University of Florida IRB-01 by (1) reading and understanding study protocols (2) obtaining HURRC approval (3) collaborating with study sponsors, clinical research coordinators, research administrators and/or Principal Investigators to obtain and provide IRB-01 accurate information (4) accurately completing Introductory Questionnaires (5) writing informed consent documents that are regulatory compliant and are at or below 8th grade reading level (6) obtaining all required signatures (7) preparing and submitting final IRB packet (8) attending IRB meetings and professionally responding to reviewer questions or comments (9) preparing IRB-01 explicit change or tabled responses (10) performing a quality assurance review of approved documents to detect inaccuracies (11) entering complete study information in database (12) scanning documents and loading files in databases (13) distributing documents to appropriate locations including Clinical Trials Support Unit and (14) maintaining up-to-date regulatory binders
Submits new projects to Western Institutional Review Board by (1) reading and understanding study protocols (2) collaborating with study sponsors, clinical research coordinators, research administrators and/or Principal Investigators to obtain and provide WIRB accurate information (3) accurately completing WIRB submission forms (4) obtaining all required signatures (5) preparing and submitting final WIRB packet (6) tracking WIRB approval process (7) performing a quality assurance review of approved documents to detect inaccuracies (8) entering complete study information in database (9) scanning documents and loading files in databases (10) distributing documents to appropriate locations (11) maintaining up-to-date regulatory binders. It is essential to have awareness about which studies qualify for WIRB submission (vs. IRB-01 or NCI CIRB), as this initiates the acceptance of items of cost related to WIRB services. These submissions must be done in accordance with UFHCC CTO established guidelines, and in coordination with the Clinical Research Coordinator and also the Research Administrator(s) on the project. If the protocol does not meet the UFHCC CTO qualifications for WIRB submission, then it must be submitted through IRB-01
Submits new projects to NCI CIRB by (1) reading and understanding study protocols (2) collaborating with study sponsors, clinical research coordinators, research administrators and/or Principal Investigators to obtain and provide NCI CIRB accurate information (3) accurately completing NCI CIRB submission forms (4) obtaining all required signatures (5) preparing and submitting final NCI CIRB packet (6) tracking NCI CIRB approval process (7) performing a quality assurance review of approved documents to detect inaccuracies (8) entering complete study information in database (9) scanning documents and loading files in databases (10) distributing documents to appropriate locations (11) maintaining up-to-date regulatory binders. It is essential to have awareness about which studies qualify for NCI CIRB submission (vs. IRB-01 or WIRB). These submissions must be done in accordance with UFHCC CTO established guidelines, and in coordination with the Clinical Research Coordinator and also the Research Administrators(s) on the project. If the protocol does not meet the UFHCC CTO qualifications for NCI CIRB submission, then it must be submitted through IRB-01
Responsible for maintaining and updating an IRB tracking database. Performs quality assurance reviews of the tracking database to prevent deficiencies related to delayed re-approvals or Institutional Review Board expirations. Maintains up-to-date comprehensive regulatory and/or study binders. Copies protocols, consents and Institutional Review Board documents
Experience with Excel, Word and databases required
Required to work independently, interact professionally and possess effective writing and organizational skills

Senior Regulatory Specialist / RA Manager Resume Examples & Samples

Provide guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
This experience must include either 510(k) or PMA Submissions. Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
High energy level; positive attitude; works well under stress, Strong communicator

Regulatory Specialist Resume Examples & Samples

High School Diploma or GED equivalent
One or more years medical billing experience
Certified Patient Account Technician (CPAT/CRCR) certification
Epic experience
Prior experience working claim denials for WA. MT or AK

Accreditation / Regulatory Specialist Resume Examples & Samples

Advise Director and appropriate management staff through a written or verbal report detailing opportunities for process or practice improvement
Demonstrate current knowledge in accreditation standards and exhibit ability to implement action plans related to specific responsibilities
Identify deficiencies in standards and sets priorities for correction
Integrate knowledge and skills in the facilitation of education and implementing actions related to compliance
Monitor and evaluate trends, and follow through on action plans and activities addressing areas of non-compliance
Promote and participate in educational activities related to new standards and staff education related to the same
Represent the Department in the absence of the Director
5 years experience in acute care is required

Regulatory Specialist Advisor Resume Examples & Samples

Provide governance and oversight for related deliverables to ensure clarity, consistency and continuity in our responses to regulators
Document, track and report related deliverables and regulatory commitments
Identify and escalate to senior COO leadership issues raised during the course of regulatory engagements
Provide thoughtful, value-add challenges to proposed management action plans and strategic remediation programs
Participate in a variety of remediation topics, for instance in records retention, trade reporting, etc
Strong understanding of US Financial Services Regulatory Landscape, with a focus on Operations
Operations processing knowledge, combined with a solid and broad product knowledge (Debt, Credit, Derivatives, Collaterals) and a good understanding of underlying controls
Analytical & problem solving skills, hands-on, willing to call out and address issues as they arise, and escalate if needed
Quick learner, with a high attention to detail, accuracy and risk awareness
Flexible and adaptable to changing environments, ability to balance project deliverables with daily processes, and differentiate between real issues and noise
Strong written and oral communication, able to dissect and describe complex issues into manageable pieces
Proficiency in Microsoft Office applications, SharePoint, GFMS

Senior Regulatory Specialist Resume Examples & Samples

The Medical Device and Combination Product CMC Lead is accountable for the delivery of all regulatory milestones for less complex products through the product lifecycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures
Lead the development, communication, lifecycle management and review of the Medical Device and Combination CMC Regulatory Strategy Document for smaller-scoped projects
Lead execution of Medical Device and Combination CMC documentation including support of IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
Conduct all activities with an unwavering focus on compliance
Experience in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills
Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance, medical devices)
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Demonstrated effective leadership, communication, and interpersonal skills
At least two (2) years of relevant experience, including biological/pharmaceutical/ medical devices; manufacturing, testing, or licensure of biological products; or related fields
The candidate must be proficient in English; additional language skills are a plus

Principal Regulatory Specialist Ndiv Resume Examples & Samples

Provides analysis, advice, and expertise in North American registrations with EPA and FDA under FIFRA and FFDCA requirements in the US and with Health Canada under PCP, DIN and NHP requiremetns according to annual and strategic plans. Negotiates with government agencies on specific projects as well as broader areas of policy to achieve results in the company's favor on key issues. Identifies and initiates opportunities to participate in industry groups to realize and/or enhance corporate objectives/improvements, and to bolster the credibility of the company in the regulated community. Manages product registration for biocidal and similar products in the US and Canada and provides strategic direction and leadership to other Regulatory staff and internal business partners to ensure that activities and programs meet all applicable regulatory requirements and support the company’s strategic and operational initiatives. Also provides support for global registration of NA products
Works collaboratively with R&D, Marketing and other internal partners to determine registration actions required to meet specific regional business objectives. Works independently on problems of diverse scope requiring evaluation, originality and ingenuity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Monitors progress and reviews results with senior management
Works independently and serves as a senior technical leader and subject matter expert in the area of product registrations for NA. Works with direct supervisor for annual goals, and requires little or no instruction from management of routine work or guidance for new assignments and/or unique situations. Informs management on ability and requirements to meet priorities and project timing. Manages team planning and coordinating of projects/programs addressing key business needs and assures adequate regulatory resources are made available and are appropriately assigned, including regional regulatory staff
Participates in cross functional teams to define and plan registration work against project briefs and prioritization. Provides extensive regulatory knowledge and support to existing product lines, changes, and innovation projects in support of department, and regional objectives. Works closely, particularly with R&D, to ensure product compliance in development
Monitors proposed changes in regulations, identify potential impact on the company and suggest actions to ensure compliance and enhance the company image with regulators and customers. Proactively communicates with other functions on these issues. Interacts with industry groups, government agencies and customers. Identifies and initiates advocacy opportunities to cooperate with regulatory agencies and trade associations to realize and/or enhance corporate objectives/improvements and to bolster the credibility of the company in the regulated community
Clearly expresses self orally and in writing. Routine communication at department level and with regional business managers. Proper reporting of project updates and support working decision process, including prioritization with key stakeholders. Gives internal presentations and prepares reports for distribution outside of the department. Communicates at all levels of the company on matters of expertise. Gives presentations to technical business management and writes reports addressing business/compliance/policy issues. Provides direct supervisor with regular oral and written reports on status of projects and issues
Advanced knowledge of antimicrobial pesticide registration requirements applying to chemical products in the US and Canada, with experience in Good Laboratory Practices is critical
Advanced knowledge of FDA food contact regulations, OTC drug and cosmetic regulations is desirable
Bachelor's Degree required, Chemistry, Biology or related field is preferred
8+ years of experience working directly with antimicrobial pesticide registration requirements
Proven team and project management
Effective analytical skills and decision making abilities
Independently plan and execute complex plans with strong priority setting skills
Building effective teams, good interpersonal relationship skills

Business Office Regulatory Specialist Resume Examples & Samples

Minimum one year experience in hospital insurance regulatory billing, including Medicare, Medicaid and / or Labor & Industries (L&I)
Medical terminology and medical coding training in an accredited school or equivalent on-the-job training in a billing role
Knowledge of the revenue cycle and/or regulatory requirements as they relate to the hospital and professional billing and collections for third party insurance payers
Detailed knowledge and understanding of ICD-9, CPT, and HCPCS coding classification systems, familiar with medical terminology and its applications, insurance rules and regulations
Bachelor’s degree in Finance, Business Management or health care administration
Strong technical background including experience with automated systems
Experience working with Provider One, MECA, FSS0 and/or CWF
Proficient in working with Epic

Facilities Regulatory Specialist Resume Examples & Samples

Previous experience in a health care setting
3 years of experience in healthcare Life Safety/Fire Protection
Strong computer skills and familiarity with word processing, database management and spreadsheet development
Bachelor’s Degree; preferred in Engineering, Fire Science or related field

Study Start Up & Regulatory Specialist Resume Examples & Samples

Assumes responsibility on quality deliverables at the country level; follows project requirements and applicable country rules. Forecasts submission/approval timelines and ensures they are complied; if forecasted timelines are not reached: provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and keeps training records updated accordingly. Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.)
Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and SSUL. May serve as the primary point of contact for the PM/SSUL (or designee) during start-up on allocated projects. Reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules
Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Provides country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of legal advisor or dedicated staff, responsible for data protection at the country. Provides clear data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level
Works with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. Produces site-specific contracts from country template. Submits proposed contract and budget for site
Works with contracts lead to agree on site-specific country template contract and budget. Produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution

Project Manager Regulatory Specialist Biologist Resume Examples & Samples

Comprehensive knowledge of, and practical experience in application of USACE regulations (33 CFR Parts 320-330) and policy dealing with the USACE regulatory program
Thorough familiarity with EPA regulations (40 CFR Part 230) and USACE policy addressing compliance with Section 404(b)(1) of the Clean Water Act
Thorough familiarity with the National Environmental Policy Act, USACE regulations promulgated therefrom (33 CFR parts 230 and 325), and USACE policy dealing with environmental documentation
Thorough familiarity with USACE Regulatory Guidance Letters currently in effect
Thorough familiarity with RWQCB
Regulations related to implementation of Section 401 of the federal Clean Water Act
Regional Best Management Practices (construction and post – construction /operation requirements)
Minimum of 3 years’ experience with a regulatory or permitting arm of the USACE, at a GS-9 level or higher, OR minimum of 3 years experience obtaining regulatory clearance through USACE for both public and private applicants
Bachelor’s in one of the environmental sciences, preferably biology

Environmental Permitting & Regulatory Specialist Resume Examples & Samples

Consulting with regulatory agencies to obtain relevant data and guidance, ascertain applicable permitting requirements and processes, and identify options and alternatives for obtaining authorizations and waivers
Assisting with proposal preparation and business development activities
Experience in working with or for environmental regulatory agencies, environmental consulting, engineering and/or law firm highly desired

Senior Fuel Economy & Emissions Regulatory Specialist Resume Examples & Samples

Monitor, analyze, and communicate federal government fuel economy and emissions related developments for light duty vehicles to internal stakeholders
Collaborate with multiple stakeholders in the US and Germany to develop regulatory strategies that support company goals
Represent Mercedes-Benz in the Auto Alliance Fuel Economy Working Group and advocate for positions that support company goals
Coordinate with government agencies (EPA and NTHSA) to discuss regulatory topics
Advise the Daimler External Affairs office on technical matters related to fuel economy and emissions legislation
Bachelor of Science in an engineering field
5+ years of relevant experience
Expert knowledge of US light-duty fuel economy (GHG and CAFE) and emissions regulations
Experience working with industry groups and government agency staff
Proven ability to build strong relationships with internal and external stakeholders
Desire work in a fast paced international team environment
Demonstrated ability to work independently and exercise sound judgement
Technical understanding of passenger vehicle fuel economy and emissions technologies
Experience developing proposals for regulatory policies that align government agency and company goals

Manufacturing Regulatory Specialist Resume Examples & Samples

Reviews and analyzes bill of materials and routings to assure product configurations meet good manufacturing practices and product regulatory requirements
Maintain effective open lines of communications with all locations and affected departments regarding Item Master Engineering Data
5+ years Greif IPS manufacturing, purchasing and/or plant administration with working knowledge of IPS products good manufacturing practices and product regulatory requirements
Demonstrated skills in verbal and written communication
Ability to handle multiple tasks and projects effectively
Must be able to travel to locations

Regulatory Specialist Resume Examples & Samples

Acts as a resource concerning regulatory information for all internal and external customers
Develops and maintains productive working relationships internally and externally by demonstrating accountability for actions, enthusiasm, motivation, and commitment to patients and colleagues
Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral, and meeting format, while adhering to appropriate timelines
Maintains an organized and accessible regulatory file for site audit/monitoring visits, as per UPCI SOP
Not only identifies opportunities for quality improvement, but also actively participates in quality improvement efforts both at the departmental and organizational levels
Performs any other tasks that are assigned by CRS management to help the organization meet its mission
Supports the development of new staff and colleagues, may also serve as a preceptor
Understands the ancillary UPMC committees, various regulatory agencies and sponsor submissions as per their guidelines. This includes an understanding of: preparing, submitting and tracking protocol requirements through the initial approval process, preparing and submitting modifications, annual renewals, annual reports, and fiscal forms, as well as preparing and reporting all safety and compliance events
Understands the process for compiling disease center Data Safety & Monitoring Board (DSMB) meeting agendas and recording, disseminating, and submitting the minutes from the meeting to the appropriate regulatory bodies
Uses a variety of resources and strategies to manage protocols and to ensure compliance with protocol procedures and all reporting requirements as well as adherence to all CRS SOPs
Assist in verifying the accuracy of and managing final documents for department-wide use
Assist in the coordination of UPCI Protocol Review Committee meetings and associated tasks, as needed
Share responsibility of study team maintenance in CTMA, including training verification and compliance
Process required documents as need for the research protocols
Assist non-CRS departments with database access and other CTMA-related items
Create study-specific safety report coversheets and compile and process safety reports for PI review and signature
Assist with audit preparation
Audit electronic regulatory files to ensure proper filing
Assist in entering protocol information and study status updates into CTMA
Knowledge of clinical research trials regulations, (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is essential
1+ years experience in drug development, regulatory or clinical operations functions is preferred
Exceptional writing, planning, and organizational skills are required to prepare clinical study protocols, regulatory submissions and various scientific and medical-related reports to contribute to the overall Clinical and Regulatory effort for oncology trials
Preparation and maintenance of FDA submissions and the ability to appropriately summarize data for inclusion in requisite reports is necessary
Previous work or strong knowledge of oncology is preferred
Strong communication, presentation and computer and data base knowledge skills are required. Must be capable of functioning independently with minimal supervision as well as perform and follow up with multiple projects

Product Regulatory Specialist Resume Examples & Samples

1) Compile and maintain regulatory documentation databases or systems
2) Coordinate efforts associated with the preparation of regulatory documents or submissions
3) Analyze product complaints and make recommendations regarding their reportability
4) Develop or conduct employee regulatory training
5) Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
6) Escort government inspectors during inspections and provide post-inspection follow-up information as requested
7) Coordinate, prepare, or review regulatory submissions for domestic or international projects
8) Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
9) Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
1) Reading Comprehension -- Understanding written sentences and paragraphs in work related documents
2) Writing -- Communicating effectively in writing as appropriate for the needs of the audience
3) Critical Thinking -- Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
4) Speaking -- Talking to others to convey information effectively
5) Active Listening -- Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times
6) Complex Problem Solving -- Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions
7) Judgment and Decision Making -- Considering the relative costs and benefits of potential actions to choose the most appropriate one
8) Systems Analysis -- Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes
9) Systems Evaluation -- Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system

SSU & Regulatory Specialist Resume Examples & Samples

General - Assumes responsibility on quality deliverables at the country level; follows project requirements and applicable country rules. Forecasts submission/approval timelines and ensures they are complied; if forecasted timelines are not reached: provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and keeps training records updated accordingly. Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.)
Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and SSUL. May serve as the primary point of contact for the SSUL/PM (or designee) during start-up on allocated projects. Reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules
Local Site ID and Feasibility Support - Works with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. Produces site-specific contracts from country template. Submits proposed contract and budget for site
Local Investigator Contract and Budget Negotiator - Works with contracts lead to agree on site-specific country template contract and budget. Produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)

Regulatory Specialist / Paralegal Resume Examples & Samples

Obtain approval from state insurance departments of form and rate filings for service contracts, GAP contracts, Credit Life and Disability Policies, Contractual Liability Policies, and, including preparing submissions in accordance with state filing requirements and responding to state regulators. Communicate with state regulators and internal departments within the Company regarding form and rate submissions and compliance issues
Review and draft provisions for Credit Life and Disability Policies, service contracts, Contractual Liability Policies, and GAP contracts, and related forms to ensure compliance with applicable state laws and regulatory policies and to obtain necessary regulatory approval
Research service contract, GAP and insurance laws nationwide. Research state law to maintain compliance with applicable state laws and regulations
Work with Product Management, Risk Management and other company stakeholders on implementation and administration of approved service contracts, GAP contracts, and Credit Life and Disability Policies
Maintain and distribute status reports of pending and approved form and rate filings

Clinical Trial Regulatory Specialist Resume Examples & Samples

Compliance: Support & comply w/ the Principles of Responsibility (Kaiser Permanente Code of Conduct)
W/ guidance from PI & KPNC Clinical Trials Compliance Director, assist w/ ensuring compliance w/ KPNC IRB Standard Operating Procedures (SOP) & document applications
Assist w/ the preparation for internal & external inspections, audits & monitor visits
Assist in assuring that all site documents, including SOPs & study regulatory files, are maintained in audit-ready condition
Study Implementation: W/ direction from the PI, prepare the following IRB documents: New protocol applications; KP consent form draft; Protocol modification forms; Adverse Event/Serious Adverse Event summary for annual report; & e. IND Safety Report Summary sheet for annual report
Assist the PI & other designated research staff in the preparation, submission, & maintenance of the following study-related regulatory documents: Current & obsolete versions of protocol & consent forms; FDA form 1572 and/or 1571; Protocol violations/deviations; Serious adverse events; Current & obsolete Investigation Drug Brochures; Documentation of IRB submissions & related correspondence, reports, & letters; Current laboratory certifications & normal reference ranges; Research staff CVs & licenses, training materials, & certifications; Test article accountability forms, signature logs, etc
Perform duties such as filing, photocopying, faxing, & distributing study-related documents
W/ direction from PI, assist in preparation of annual, interim & final KPNC IRB reports
Maintain current licensure documentation including MD/RN licenses & CVs
Obtain regulatory certifications including KP laboratory state licenses, current laboratory certifications & normal reference ranges
Assist the PI w/ maintaining all study-related legal/financial documents in a confidential administrative file, if requested
Coordinate w/ the PI regarding maintenance of regulatory IRB & other documentation & procedures
Assist w/ data entry of study activities into a database program to track pertinent study activity (i.e., study enrollment, consents, protocol violations/deviations, serious adverse event reports, & IRB history)
Assist the PI & research personnel in the resolution of data queries, if applicable
Assist in study closure activities including scheduling of monitor close-out visit, preparation & collection of close-out documentation, & preparation of study files for distribution to long-term storage
Maintain long-term storage records & keep PI & Sponsor informed of any changes in the status of study records
Minimum two (2) years of general work experience required
Health care and/or research regulatory experience preferred

Human Subject Research Regulatory Specialist Resume Examples & Samples

Excellent organizational and writing skills
Ability to prioritize competing demands and adjust to changing deadlines
Ability to follow directions and work independently
Ability to work in a team atmosphere
Proficiency with a wide range of computer applications
Knowledge of federal regulations regarding research in human subjects preferred
Knowledge of medical terminology is preferred
Bachelor’s Degree or equivalent amount of experience in a medical/research or other professional environment

Clinical Research Regulatory Specialist Resume Examples & Samples

Assists with coordination of accurate quality data collection and protocol interpretation as it relates to regulatory affairs. Prepare regulatory documents, as assigned, for successful submissions to KPNW's Institutional Review Board. These may include: review requests for new protocols, amended protocols, investigative drug brochures, IND safety reports, serious adverse event reporting, annual reports, and changes to informed consents and protocol deviations/violations. Collaborate with Compliance Coordinator and study team members to clarify scientific and clinical issues. Practice according to professional, legal, and ethical standards. Collaborate in the development and implementation of systems and reports to support department and regulatory needs. Collaborate with Compliance Coordinator to evaluate systems and processes to promote effective resource utilization
Assist with coordination of specific regulatory assignments to support the goals of the CRSS department, Investigators, the studies and their sponsors. Prepare and submit regulatory documents to sponsors as appropriate. Ensure study administrative regulatory files are accurate and up to date. Assist in development of a quality management process within the department that includes quality control, quality assurance, and quality improvement. Communicate study-related issues, such as protocol violations and patient safety to appropriate persons. Assist with the organization of all regulatory documents and maintain the database with all pertinent regulatory information. Apply knowledge of GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), Institutional Review Board, and FDA (Federal Drug Administration) rules and regulations that apply to human subjects research. Anticipate fluctuations in work flow and make appropriate adjustments to meet standards and deadlines. Assist with all regulatory audits. Provide assistance with review and updates of department policies and procedures to ensure compliance with CHR/KP standards as well as government regulations
Foster channels of communication between research staff, PI's and KPNW Research Subject Protection Office (RSPO) to solve problems effectively. Establish positive working relationships with Principal Investigators, RSPO staff and other members of the study team to ensure timely, accurate verbal and written communication of study related regulatory activities. Provide timely, accurate communication to appropriate study team members of changes in regulatory interpretations and/or reporting requirements as required by the RSPO. Collaborate with the Research Subject Protection Office (RSPO) to ensure compliance with all institutional and regulatory requirements. Demonstrate a thorough knowledge of communication skills by contributing productively to problem solving and conflict resolution
Functions as a member of a multi-disciplinary team. Act as a role model, developing and participating in collaborative relationships with other staff members. Integrate the department purpose/mission/vision/values into practice. Performs other duties as requested
Minimum two (2) years in a clinical trial setting
Minimum two (2) years of research experience in clinical research setting and experience abstracting data
Minimum two (2) years of in clinical trial setting
Thorough knowledge of MS Office software and data base management
Knowledge of FDA regulations as they pertain to the protection of human subjects

Safety & Regulatory Specialist Resume Examples & Samples

5+ years of experience in a manufacturing, logistics or related environment
3+ years’ experience in a Safety / Regulatory role in a logistics or manufacturing environment, including internal and external audits
Immigration sponsorship not available for this role
Bachelor’s Degree in safety or other technical discipline (e.g. Chemistry, Chemical Engineering, Biology) or Operations Management / Supply Chain Management
Experience with hazardous materials and process safety management
Familiarity with 49 CFR, Pipeline and Hazardous Materials Safety Administration, Code of Federal Regulations, ocean regulation (IMDG) and/or air regulation (IATA)
Experience in a World Class logistics and / or manufacturing environment
1+ years’ experience in cross-functional project or program management

Regulatory Specialist On-call Resume Examples & Samples

BS/MS/PHD in biology, ecology, environmental science or a related discipline
Minimum of 4+ demonstrated years of experience in field
Jurisdictional Determinations (Waters of the U.S. and State) using the Arid West Supplement and Ordinary High Water Mark Manual
Experience completing small project permit applications and supporting documents under the Clean Water Act (e.g., CWA Section 401 and 404), Section 1600 of the State Fish and Game Code, Section 7 of the Endangered Species Act for the Corps, RWQCB, and CDFW
Demonstrated ability to interface with clients, prepare meeting agenda, and meeting minutes
Demonstrated ability to work in a team environment and with regulatory agency personnel
Approved Jurisdictional Determinations (Significant Nexus Analysis)
Preparing Corps’ Section 404 Impact Analysis, Environmental Assessments, Public Interest Review, and 404(b)(1) Alternatives Analyses
Preparing Biological Assessments or other documents in support of consultations pursuant to Section 7 and/or 10 of the Endangered Species Act
Experience with the California Rapid Assessment Method (CRAM)
Programmatic Permitting (developing RGPs, SAMPs, or other programmatic permits)
Compensatory Mitigation Planning (HMMP, Mitigation Banks, and/or In-lieu Fee Programs)
Small or large proposal preparation

QA & Regulatory Specialist Resume Examples & Samples

Oversee all quality functions in the facility and ensure systems adhere to Quality Master Plan
Provide direction, support, and communication to all employees in the facility regarding quality systems, guidelines, and standards compliance, such as QA Inspectors at all locations
Lead product incident problem solving and resolution. Identify causes to product quality incidents by using direct staff and collaborating with operations peers to quickly understand issue. Monitor the third party laboratory test and lead to control product and prevent further incident by implementing effective solutions. Document and track incident reports, corrective actions, and material reviews
Complete final review and approval of product specifications, production batch records, laboratory raw data, labels, and COAs for raw materials and finished products
Complete internal audits to ensure policies and regulations of FDA (cGMP), TDA, third party certifiers and internal SOPs are followed
Maintain and monitor HACCP Program to insure plant sanitation requirements are met
Interface with outside governmental agencies, such as: USDA, FDA, TDA, etc. and to consumers and customers through investigation and response to complaints
Interface with customers for their audit requirements of our production facilities through continuous monitoring of the Supplier Qualification Program
Maintain records of internal and external deviations, incident reports, corrective/preventative actions and employee training
Monitor and track instrument calibrations
Ensure staff follows all safety procedures
Perform any other related duties assigned

Junior Regulatory Specialist Resume Examples & Samples

Bachelor’s or Master’s degree in scientific or technical field
Very good computer skills (work experience with complex computer systems and databases)
Fluent Polish and English (both written and spoken)
Orientation to details, preciseness
Service orientation, customer-focused
Ability to work carefully under time constraints
Good team worker
Work experience in an international environment would be an additional advantage
Provide support to GRA Labelling Staff to help ensure quality and consistency of labelling documentation content and storage
Management of GRA Labelling data in GSK databases and systems including generation of Global Project Plans for Global PI dispatch. Ensure information is correctly captured to agreed schedules
Management of EU PI annexes for products registered via the EU centralised procedure, including coordination of translations during the linguistic review process, interaction with LOCs and submission to EMA
Supporting GRA-Labelling processes and systems in accordance with GSK policies and procedures
Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling

Regulatory Specialist, Labelling Coordinator Resume Examples & Samples

2-3 years of experience in regulatory
Data entry experience within an office environment
Bachelor’s or Master’s degree in scientific or technical field
Very good computer skills (work experience with complex computer systems and databases)
Fluent Polish and English (both written and spoken)
High orientation to details, preciseness
Service orientation, customer-focused
Ability to work carefully under time constraints
Good team worker
Knowledge of worldwide CMC regulatory requirements
Work experience in an international environment would be an additional advantage
Provide support to GRA Labelling Staff to help ensure quality and consistency of labelling documentation content and storage
Management of GRA Labelling data in GSK databases and systems including generation of Global Project Plans for Global PI dispatch. Ensure information is correctly captured to agreed schedules
Management of EU PI annexes for products registered via the EU centralised procedure, including coordination of translations during the linguistic review process, interaction with LOCs and submission to EMA
Supporting GRA-Labelling processes and systems in accordance with GSK policies and procedures
Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling

Research Regulatory Specialist Resume Examples & Samples

Files. Maintains a paper and/or electronic study trial file. Continually updates and prepares files for audits
Notification of Changes. Responsible for notifying IRB of trial changes, enrollment status, and protocol deviations including submission of continuing review data
Compliance. Provides guidance and instructions to research personnel on regulatory affairs requirements and procedures. Assist with revisions to Informed Consent Form (ICF) in compliance with sponsor and IRB requests
Grants and Contracts. Provides grant support including submission of legal documents and associated routing forms to Office Research Administration and OU Medical Center
As Needed. Performs various duties as needed to successfully fulfill the functions of the position
High level of organization skills
Knowledge of compliance and regulatory concepts, guidelines, and principles
Proficiency with Microsoft Office Suite and other software systems

Regulatory Specialist Resume Examples & Samples

Good Knowledge of cosmetic and chemical regulations
Excellent communication skills (written & verbal); Fluent in English, other languages are an advantage
Customer focused
Team player in an international business environment
Proficient in Microsoft office programs
Adaptable
Passionate about learning and solving complex problems
Attention to detail
Manages pressure and stay composed in stressful situations
Bachelor 's or HBO degree preferably in chemistry, cosmetology, Toxicology
3 to 5 years of work experience in Regulatory Affairs in fragrance/Chemical or cosmetics industry

Regulatory Specialist Resume Examples & Samples

Previous experience with CMS and Joint Commission standards
Minimum of 5 years of experience in a healthcare setting, with previous acute care RN experience
Bachelor's Degree in Nursing
Master's Degree in a related field
Experience with managing and interpreting data

Ops Regulatory Specialist Ii Dbpr Resume Examples & Samples

An associate’s degree or higher from an accredited college or university with a concentration in business administration, accounting, finance, economics, information systems, management or marketing
Two years of professional or nonprofessional experience in academic advising, college admission and enrollment, college registration, curriculum design, or a related field may be substituted for the required college education
*Applicants must complete all fields in the Candidate Profile. Work history with month and year, hours worked and formal education are required to qualify for this position. Responses to Qualifying Questions must be verifiable in the Candidate Profile. Resumes and other documentation can be attached to provide additional information.***
Reviews the more complex applications for licensure to determine eligibility for registration, certification, or licensure; independently evaluates qualifications and licensure criteria in accordance with law and rules
Performs professional regulation activities which include the more complex complaint analysis, investigation services, examination services, board office services, and other regulatory related services
Prepares agenda and materials for board meetings and committee meetings
Reviews curriculum, transcripts, degrees and other educational materials of applicants having received education and training in foreign countries in order to determine applicant eligibility for certification and licensure, and the continuation of practice in the respective profession
Performs continuing research to establish current accreditation status of all colleges and universities, and status of approved continuing education providers and provider courses or programs
Reviews complex background information to determine eligibility for licensure
Composes and authorizes preparation of correspondence regarding licensure and regulation of professionals and facilities and other licenser
Conducts continuing analysis of the more difficult consumer complaints and/or unusual certification and licensure applications requiring extensive research and professional judgment
Recommends and reviews improvements in procedures
Provides applicants personal guidance regarding certification and licensure
Performs related work as required by management
Ability to read and understand college transcripts
Ability to use Microsoft Office programs like Excel, Word, and PowerPoint
Ability to compile, organize and analyze data
Ability to understand and apply Florida Statutes, rules, policies and procedures for licensing and regulation of professionals and facilities, and consumer protection
Ability to provide consultative assistance to others
Ability to plan, organize and coordinate work activities
Ability to communicate and deal with people effectively
Ability to establish and maintain effective working relationships with others

Regulatory Specialist Resume Examples & Samples

Provides assistance to the supervisor relating to public records requests, which includes conducting research, retrieving files in OnBase and from the warehouse
Provides assistance in reviewing files and removing any confidential materials in accordance with statutory requirements
Responsible for maintaining and updating compliance records relating to disciplinary actions, including monitoring fine payments, education requirements and other discipline for FREC and FREAB
Responsible for updating final agency actions for the DRE web page
Provides support in coordinating the FREC and FREAB general and probable cause meetings, which includes gathering and distributing supporting documentation to the members of the FREC and FREAB and various individuals within the department and updating the calendar for FREC general and Probable Cause Meetings
Provides assistance in completing duties related to action items upon conclusion of the FREC and FREAB general meetings
Processes licensure and application related documents for appraisal licensees
Prepares FREC and FREAB travel which may include assisting with coordinating travel arrangement
Knowledge of and ability to use Microsoft Office programs, Versa: Regulation, and OnBase
Basic knowledge of Chapter 475 F.S. and Fla. Adm. Code 61J2
Basic knowledge of Chapter 119 and 455, F.S. relating to public record requests
Ability to work with minimum supervision and to work in concert with peers
Ability to deal effectively with people and handle difficult individuals over the phone
Ability to plan, organize and coordinate work assignments
Ability to communicate effectively orally and in writing

Regulatory Specialist Resume Examples & Samples

Lead projects to improve global regulatory equipment compliance processes and outcomes
Work with R&D and consulting partners to establish policy and design guidance to drive globally-compliant equipment innovations
Lead and optimize compliance processes for equipment workstreams
Identify opportunities and lead projects to improve regulatory landscape for Ecolab equipment offerings
Develop KPIs for product compliance delivery and field support
Develop global registration strategies with regional regulatory partners
Work closely with Divisions to support field associates with equipment compliance requests
Manage multiple complex development projects comprised of members from R&D, Supply Chain, and Marketing as well as external consulting partners across regions
Provide Regulatory guidance to RD&E and Divisional clients in the design, development, and commercialization of Ecolab equipment systems by defining relevant certification & compliance requirements governed by agencies including but not limited to UL, NSF, CSA, ASSE, IAPMO, COLA
Prepare and submit agency registration applications for equipment systems to secure marketing authorization. Monitor progress of registration activity and negotiate with agency representatives to resolve issues encountered during the registration process
Establish and maintain well organized files related to registration of equipment systems to ensure that listings are appropriately renewed
Maintain equipment compliance files
Bachelor’s degree in engineering or science related field
5+ years professional experience
Proven project management, communication, and problem solving skills
Familiar with product lifecycle management and engineering change process
Working knowledge of the global equipment regulatory industry with experience with the following organizations or compliance schemes: NRTL, CE, UL, CSA, NSF, INMETRO, NOM, WRAS, ASSE, IAPMO, and others
Familiarity with electrical and plumbing principles including electrical circuits, EMC, and back flow methods and devices
Experience working with and negotiating with AHJ representatives
PMP or proven record of successfully executing complex multi-national projects
Ability to explain complex ideas to a diverse range of audiences
Demonstrated success coordinating activities with internal businesses and external customers or business partners
Good written and verbal communication skills
Working knowledge of Microsoft SharePoint or other CMS

100

Wireless Real Estate & Regulatory Specialist Resume Examples & Samples

Lead multiple small to medium projects or one large project
Provide guidance to the regional network teams concerning lease agreements. Facilitate meetings between municipalities and regional engineering teams. Interface with Leadership and provide presentations to leadership teams
Interface with City managers, City Council, Legal
Facilitate meetings and compose presentations
Perform project management activities-Maintain project tracker and facilitate area wide project call
Develop resolutions to complex problems that require the use of creativity and makes decisions that impact projects andRegion
Knowledge of Existing & Emerging Technologies-
Understand network evolution and how RE/Regulatory applies to technology
Review and interpret Master agreements. Work with legal to review and amend agreements
Interpret and understand VZW policies and procedures and effectively communicate them to third party vendors and internal network teams
Understand leasing agreements. Review proposed agreements and work with legal and management to interpret and evaluate agreements
Identify and resolve network critical or site critical issues requiring immediate escalation to the management team
Provide guidance and feedback to network leadership regarding Master Agreements
Successfully negotiate and work with all types of Landlords and their agents, and vendors in order to preserve the Company’s rights and meet the Company’s contractual and regulatory obligations
Cold call municipalities and utilities
Present VZW network view to City leaders
Solid understanding of zoning, permitting and FCC regulations
Collaborate with HQ RE./Regulatory in the negotiation of national agreements

101

Regulatory Specialist, Food Colors Resume Examples & Samples

Ability to interpret proposed rules and regulations in order to formulate the appropriate customer response
Keeps abreast of changes in regulations, including attending trade conferences and seminars
Completion of customer documents specific to Regulatory compliance
Resolution of customer complaints related to Regulatory issues
Identification of sales restriction by market and/or region as dictated by Regulatory statutes
Provides product information to internal and external customers with respect to domestic and foreign regulatory requirements in the area of colors regulations and related laws
Reviews customer’s specifications and determines company’s ability to comply. Communicates compliance with appropriate parties
Facilitates both national and international product registrations, regulatory submissions and reports (FDA, EPA, and EU collaboration required)
Audits new product set up
Reviews and makes necessary revisions to technical data sheets, safety data sheets, and other standard regulatory documents, as needed before submission to internal and external customers
Independently prepares documentation for new products and current events
Strong interpersonal and communications skills, and organizational and planning abilities needed to handle multiple tasks concurrently
Working knowledge of how to determine global chemical inventory (TSCA, etc.) for products
Good computer skills, with the flexibility to learn web technology, SAP and ERP systems, and document control computer systems
Continually seeks improved methods and procedures to better serve customers, internal and external, and facilitates their implementation
Trade association representation
Developed knowledge of industry specific laws
Follow regulatory standard operating procedures and has general knowledge of manufacturing processes used to manufacture products
Able to apply regulatory knowledge to make compliance decisions on products we manufacture
Learn multiple business units and manufacturing processes to make regulatory decisions
Helps with development of standard operating procedures
Requires organizational skills to maintain large volumes of information in various stages of completion
Ability to perform efficiently and amicably under hectic and stressful conditions while still being flexible enough to react to the daily emergencies that occur
Work is fast paced and involves high stress due to the urgency of multiple customer projects
Ability to react quickly to customer needs and work with minimal supervision
Bachelor’s degree in science discipline or related field
Minimum of three years of regulatory experience

102

Compliance, Legal, & Regulatory Specialist Resume Examples & Samples

Juris Doctorate (J.D.)
At least three years of experience in the health care regulatory environment supporting healthcare compliance activities with substantive experience in risk assessment, auditing, project management, training, policy and procedure drafting, and the development, implementation, or support of an effective Compliance Program
Must be a person with a high degree of integrity and trust, and the ability to work both independently and as part of a team
Successful candidate will exhibit a willingness to jump in and take on new responsibilities, as needed, to complete projects
Prior experience working with the AdvaMed Code of Ethics preferred
Prior experience supporting businesses in the home healthcare market and/or interactions with Durable Medical Equipment providers preferred
The ability to successfully interact with employees at every level of the organization and the professional presence necessary to represent the Company
Certification in Healthcare Compliance preferred

103

Regulatory Specialist Resume Examples & Samples

Special project management, coordination and support
Conduct research on regulatory issues, including but not limited to state and federal regulations of pharmaceutical and medical device products. Overtime, develop deep understanding of core state and federal regulations
Engage internal customers in written and verbal communications concerning QA/RA procedures, and state, federal and international regulatory requirements. Facilitate relationship building with these internal customers
Engage in continuous learning about Medline products and processes
Participate in other regulatory affairs projects as assigned

104

Regulatory Specialist / Biologist Resume Examples & Samples

Minimum of 3 years? experience with a regulatory or permitting arm of the USACE, or minimum of 2 years? experience obtaining regulatory clearance through USACE for both public and private applicants
Bachelor?s in one of the environmental sciences, preferably biology
Demonstrated proficiency in MS Office software applications, especially Word and Excel; as well as Internet usage

105

Associate Regulatory Specialist Resume Examples & Samples

Provide Hazard Communication support to Ecolab business units
Author safety data sheets (SDS) for Ecolab business units
Conduct chemical- and raw material-level hazard characterizations
System data maintenance for SAP Software Solutions system
Address hazard communication-related questions from Ecolab business units and customers
Demonstrate expertise with the Globally Harmonized System for Classification and Labelling of
Chemicals (GHS)
Develop proficiency in regulations applicable to specific areas of responsibility as required (e.g.,
California Proposition 65)
Provide guidance on prospective classifications for experimental products
Participate in internal Ecolab research- and business-related meetings and projects
Act as point of contact for global questions related to toxicology and product classifications
Manage the progress and training materials related to SDS authoring and chemical and raw
Material data entry (e.g. SOP)
Bachelor’s degree, preferably in a technical field such as biology, chemistry or computer science

106

Protocol Development & Regulatory Specialist Resume Examples & Samples

Managing and coordinating the development of new investigator initiated trials and all subsequent amendments with the PI (Principal Investigator), study team, review committees, and regulatory organizations ensuring Federal, State, University, sponsor, and HDFCCC standards and policies are met
Communicating with industry sponsors regarding protocol development (i.e., obtaining letter of cross reference, maintaining version control edits, and incorporating sponsor-specific safety reporting and with other internal committees such as disease site committee, the Protocol Review Committee (PRC), and Data Safety and Monitoring Committee (DSMC)
Submitting to the IRB, FDA, and various safety committees
Developing informed consent documents
Tracking and submitting IND/IDE submissions including initial applications, amendments, and annual reports to the FDA
Using various databases, application systems, and templates, such as clinical trials management systems, trial databases, and IRB and HDFCCC templates
Maintaining workload and tracking timelines of events during the development of new trials and all subsequent submissions
Work with team members to development and maintain best practices for the office and improve timelines and quality
Bachelor’s degree in biological sciences, public health, psychology, sociology, or another research-focused discipline or equivalent education and experience in clinical research
Three years of experience in clinical research to include, but not limited to, protocol editing, clinical research coordination, clinical research associate, regulatory coordinator, and/or clinical research project or program management
Minimum two years of experience preparing submissions for the Institutional Review Board, the FDA, other regulatory organizations and/or scientific review committees
Minimum one year working on investigator-initiated studies, including, but not limited to, writing consent forms, coordinating development of protocols, and managing timelines for various submissions
Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents
Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology
Understanding of clinical research methods and operations, the Institutional Review Board, the Food and Drug Administration IND and IDE submission processes, NIH RAC submission process, and submitted to other research review committees and regulatory bodies
Proficiency using computers in a Windows environment, including advanced skills in Microsoft Word and Excel
Demonstrated self-discipline and sound, independent judgment completing complex assignments
Master’s degree in research focused discipline
RAC, CCRP, ACRP
UCSF experience
Experience using search engines and writing literature reviews
Proficiency with bibliography management software such as EndNote, Papyrus or Reference Manager

107

Regulatory Specialist for Oncology Research Resume Examples & Samples

4-year degree in related field or equivalent experience required
Possesses up to date knowledge of the profession and industry; accesses and uses other expert resources when appropriate
3 years in Clinical Research experience required, 2 years regulatory affairs required, 2 years oncology experience is preferred
Shows Work Commitment: Sets high standards of performance; pursues aggressive goals and works efficiently to achieve them
Discretionary decision-making and independent judgment skills. Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines. Must be precise, thorough, reliable, and perform daily activities with minimal supervision
Knowledge of clinical research process and regulations. Demonstrated analytical skills; ability to create ad hoc reports, tracking tools, and professional documents; and the ability to interpret and apply complex government regulations

108

Compliance & Regulatory Specialist Resume Examples & Samples

Provide support and coordination for compliance and regulatory-related projects
Apply cGMP (Current Good Manufacturing Practice) concepts into validation and change control, supplier quality management, quality system documentation review, and Development and/or modification of quality systems and other cGMP processes
Create, prepare and review technical reports
Conduct internal and external/supplier audits
Perform activities supporting the supplier quality management program, including supplier evaluations, audits, vendor requests/inquiries, and supplier complaint follow-up
Interact with clients regarding compliance/regulatory issues
Maintain current knowledge base of existing and emerging regulations by developing cGMP/Compliance and/or Regulatory policies and training for staff
Conduct and/or annual product review activities
Coordinate, prepare and review regulatory filing submissions
Expected to cross-train in identified quality unit activities outside of the Compliance and Regulatory department in a supporting capacity
Bachelor’s degree in a scientific discipline or equivalent with 3+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment (sterile manufacturing (injectables) preferred)
Technical writing experience is required
Working knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations
Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing
Experience with Supplier Quality Management programs and/or auditing is preferred
Knowledge of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC)) format, content, and filing requirements for US and EU. Other jurisdictions a plus
Must be a detail oriented team player with effective planning, analytical thinking, organization, and execution skills
Must have proficiency in the Microsoft Office Suite
Excellent communication skills with internal and external personnel is essential
Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines
Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred

109

Wireless Real Estate & Regulatory Specialist Resume Examples & Samples

Weekly reporting and budget oversight
Resolve complex issues that cause delays with projects
Review and interpret lease verbiage, understand leasing agreements, successfully negotiate and work all types of agreements with landowners
Interpret and understand Verizon policies and procedures
Review and interpret zoning and permitting requirements
Facilitate meetings

110

Senior Regulatory Specialist Resume Examples & Samples

Demonstrates advanced competency in performing complex regulatory work and demonstrates advanced knowledge of relevant rules, regulations, guidelines and industry practices
Participates in RSA examination strategy meetings with District Office staff
Regularly monitors and reports on the status of the national RSA examination program
Identifies and leads efforts to prioritize enhancement opportunities for the national examination program
Ensures that all RSA related documents maintained by the department are current and accurate
Analyzes proposed changes to the RSA exam process as requested by clients, rule proposals, amendments, and new RSA rules to determine impact to FINRA examination responsibilities and resources
Responsible for analysis of rule books of RSA clients to determine appropriate examination content coverage
Writes examination policies and procedures, fully addressing applicable rules and regulations, and makes initial determinations as to changes to FINRA examination policies and procedures that may require staff training
Participates in acceptance testing and/or task forces providing feedback and guidance to ensure examination and related programs are efficient and effective
Assists with training on RSA-related issues, as needed. Keeps management updated on notable trends in industry practices, products and procedures
Coordinates and communicates effectively with other FINRA personnel, self-regulatory organizations and agencies
Provides other FINRA Departments, SROs, member firms and others with timely, accurate responses to inquiries
Provides guidance to examiners about applicable rules and regulations in the context of FINRA's RSA examination and other regulatory programs
Leads multiple and complex projects concurrently
Bachelor's degree and a minimum of seven (7) to eight (8) years of Regulatory/Compliance or related experience
Strong analysis skills, writing skills, communication skills, organizational skills, and excellent detail orientation are essential

111

Senior Regulatory Specialist Global Regulatory Affairs & Clinical Safety Resume Examples & Samples

The CMC Product Lead is accountable for the delivery of all regulatory milestones for less complex products through the product lifecycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures
Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects
Lead execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
Conduct all activities with an unwavering focus on compliance
Experience in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills
Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance)
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Demonstrated effective leadership, communication, and interpersonal skills
At least two (2) years of relevant experience with an advanced degree, including biological/pharmaceutical research; manufacturing, testing, or licensure of vaccine or biological products
Must be proficient in English

112

Clinical Research Monitor & Regulatory Specialist Resume Examples & Samples

Bachelors Degree with~ 3 years clinical research experience including experience with CRO/sponsor monitoring/auditing in pharmaceutical industry or equivalent combination of education/related experience. Oncology monitoring experience preferred
Working knowledge of disease state and an understanding of regulatory requirements
Knowledge of study protocols and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)
In depth knowledge of GCP regulations, 21CFR regulations, IND and IDE processes, quality systems, quality assurance, quality control and GCP quality audits
Experience in regulatory inspections, vendor audits, and vendor qualification, and internal audits
Excellent interpersonal/communication skills (verbally and in writing)
Proficiency with Microsoft Office (Excel, Word, Project, PowerPoint)
Ability to work effectively both independently and as part of a team
Detail oriented and excellent organizational skills
Professional demeanor and the ability to work effectively in a (sometimes) dead-line driven environment
Willingness to travel to in-state site locations
Willingness to work some (occasional) weekends when necessary

113

Clinical Trials Regulatory Specialist Resume Examples & Samples

Bachelor's degree preferred, with two (2) years of regulatory work including sponsors, IRB, clinical site staff and physicians
The ability to problem solve complex issues across multiple clinical sites, working effectively with cross-functional teams
Flexible and dependable

114

Associate Regulatory Specialist Resume Examples & Samples

Bachelor’s degree in Chemistry, Biology, Toxicology or related discipline
1+ years related professional experience
Excellent database management skills
Self Starter
Ability to drive others to get things done
Excellent negotiation and people skills
Product registration or certification experience
Experience with NSF International standards and accreditation
EPIC, CAS and SAP system experience
Familiarity with regulatory programs such as EPA, FDA, OSHA, DOT, DIN, CFIA and other Federal/State regulations

115

Regulatory Specialist Resume Examples & Samples

Receive documents from various sources and review for completeness and suitability for submission to FDA
Reviews engineering change requests to assess impact to regulatory submissions
Responsible for writing import authorization memos to release ship flags to international countries
Assure the regulations and laws regarding 510(k) and PMA submissions meet compliance
Assure Technical and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment
At least three to five years of work experience
Experience in post-market regulatory tasks. Strong knowledge of change control process
Understanding of scientific disciplines required
Understanding of FDA regulations governing 510(k)s, PMAs, Software cybersecurity requirements, submission processes, and submission content
Understanding of international regulatory submission requirements for IVDs
Knowledge of engineering controls
Strong computer skills required.Search Jobs US

116

Regulatory Specialist, Food Colors Resume Examples & Samples

Trade association committee representation
Provides product information to internal and external customers with respect to domestic and foreign regulatory requirements in the area of color regulations and related laws
Audits new product compliance
Resource and mentor colleagues with less experience
Able to troubleshoot and resolve system related issues
Manage and execute assigned projects
Bachelor’s degree in science discipline or related field; master’s degree preferred
Minimum of five years of regulatory experience
Knowledge of industry specific laws
Follow regulatory standard operating procedures and has in-depth knowledge of manufacturing processes used to manufacture products

117

Ops Regulatory Specialist Ii Dbpr Resume Examples & Samples

High School Diploma
One year working in a computer-based environment
One year of customer service experience in a telephonic or electronic environment
Preference will be given to applicants who have an associate’s degree or higher from an accredited college or university with a concentration in business administration, accounting, finance, economics, information systems, management or marketing. Preference will also be given to applicants who have two years of professional or nonprofessional experience in academic advising, college admission and enrollment, college registration, curriculum design, or a related field may be substituted for the required college education.**

118

Research Regulatory Specialist Resume Examples & Samples

Maintenance of regulatory master files for industry & investigator initiated oncology trials
Aid in the development of protocol specific standard operation procedures
Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects
Obtain continuing approvals from various committees and organizations (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee, Radiation Committee
Assist the clinical team with the development and implementation of amendments
Meet & correspond with sponsor and/ or CROs during monitoring visits and ensure study regulatory files are up to date & audit ready
Upload any contractual or budgetary changes in internal system for completion by appropriate department at NYU
Accurate preparation of annual renewals & study closure for IRB & sponsors
Submission of study amendments in a timely fashion including changes to the protocol, consent forms and other study documents

119

Research Regulatory Specialist Resume Examples & Samples

Creation of regulatory master files for industry & investigator initiated oncology trials
Assisting with the development and implementation of local protocols and grants (including consent forms, study calendars, letter of intents (LOIs), and single patient INDs to ensure they conform to the sponsor & NYU specifications
Assist with organizing site initiation visits with sponsor/ CRO & clinical team
Assist the clinical team in the development of trial specific training tools for the study staff
Obtain initial approval from various committees (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee, Radiation Committee. External: FDA, NIH, NCI, Cooperative Groups)
Aid in the development of departmental standard operation procedures
Conduct Pre-study visits ensure site meets all requirements to conduct the clinical trial
Uploading contracts & budgets in internal system (CDAs & CTAs) for completion by the appropriate legal department at NYU

120

Food Regulatory Specialist Resume Examples & Samples

Oversee compliance to government regulations on customer documentation, food labeling, nutritional panels, as well as, international country review and compliance
Represent regulatory in cross-functional teams and communicate with management to maintain legal compliance and integrity
Legal evaluation of the company products for the intended industry
Responsible for the creation, issuance and updating of product documentation which could include documents such as: specifications, allergens, GMO, labeling, country compliance, organic, SDS, nutritional information, and other regulatory documentation to customers and technical personnel as needed
Vendor communication, interpretation of vendor documents and maintenance of raw material database
USDA label sketch approvals – responsible for creating and submitting to the agency for approval
Communicate with external governing agencies and trade associations as required
Evaluates formula revisions and communicates labeling modifications to customers
Complies with the food safety management system and participates as required to ensure food safety and ISO/Food Safety certification
Perform other duties and special assignments as required

121

Mifid & Regulatory Specialist Sector Focus Resume Examples & Samples

You will provide competent technical regulatory advice to our clients in financial institutions
You will identify legal requirements, and implement them in distribution models, service models, processes and business operations
You will demonstrate a pro-active, client-oriented attitude and identify additional sales opportunities
You will act as an interface with our clients, both locally and on EMEIA level, and step up to the challenge of representing EY in front of external parties

122

Lead Investigator Initiated Trials Protocol Development & Regulatory Specialist Resume Examples & Samples

Bachelor's degree in public health, sociology, psychology, biology, or other research related area and / or equivalent experience/training in clinical research support and/or supervising
At least 2 years clinical trials management experience, preferably in oncology, or related management experience
Ability to apply a skilled decision making to a complex array of issues, mental flexibility, and creativity to relevant compliance area
Skill in managing established relationships with regulatory agencies, such as IRB, FDA, NCI, and safety committees, for relevant compliance area
Managerial or equivalent leadership experience such as training of staff or leading meetings, preferably clinical trials or regulatory affairs
Proven knowledge of and experience applying Federal, State, and/or University-level regulations to daily work
Proven ability to work collaboratively in a team environment
Proven proficiency working with various databases, clinical trial management systems, and MS Office
Master’s degree in public health, sociology, psychology, biology, or other research related area
Experience working with medical staff and Principle Investigators
Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (SOCRA)
Regulatory Affairs Certification (RAC)
Other clinical research related certifications

123

Regulatory Specialist Resume Examples & Samples

Demonstrates fundamental understanding of US Oncology Research processes, business and operational goals. Collaborates with team initiatives and serves as support for senior members of the team to deliver action items and products to our sites, IRB and sponsor/CRO clients. Understands the importance of building relationships at McKesson with key stakeholder and business partners. Ensures accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Analyzes regulatory requirements, identify potential conflicts, and have thorough knowledge and ability to apply federal regulations and USOR policies. Maintains awareness, excellent comprehension and appropriate application of relevant regulations. (30%)
Investigates complex and unusual customer requests and complaints, develops remediation plan and leads implementation. Ensures all assigned trial regulatory obligations are managed compliantly with FDA regulations. Maintains compliance and integrity of study trial master file in paper/electronic formats. Ensures file is continuously updated and prepared for audits. Hosts and prepares interim monitoring visits to external clients and speaks to outstanding issues and works to resolve them. Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Clinical Operations and IRB. Provide local expertise to internal teams during initial and on-going project timelines planning. Monitor project development on an ongoing basis and implement changes as needed. (25%)
Manages, completes, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, deviations, etc. Reviews study procedures to determine whether supporting documents (i.e. patient diaries and surveys) are required. Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines. Conduct regulatory reviews prior to committee consideration to ensure submitted research is in compliance with submission requirements with state, Federal regulations and USOR policies. Facilitates IRB approval and renewal of clinical protocols, IDB, advertising materials, consent forms and other items required by federal research regulations. (20%)
Establishes process and timelines for clinical trial activation for regulatory readiness on behalf of each participating site as well as ongoing study maintenance phase. High level of competency with computer software, including databases and database management, spreadsheet applications, development and presentation of PowerPoint slides, and training/educational materials. Creates e-signature templates and coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications and tracks collection progress through internal tracking systems. Communicates daily with sites to get documentation completed. Escalates to manager for non-responsive sites. Reviews each document for regulatory compliance, accepts or rejects documents. Creates and executes regulatory strategies for clinical trial applications. Exercises good judgment when making decisions. Perform quality control of documents provided by sites. (10%)
Leads coordination of trans-departmental review of patient informed consent. Notifies IRB of trial changes, enrollment status and protocol deviations. Collaborates with representatives from multiple departments including project management, finance and IRB; research staff including the network principal investigator; and external clients including study sponsor and sponsor’s authorized representatives to analyze patient informed consent document for accuracy, consistency and adherence to study protocol, budget and regulatory requirements. (10%)
Other duties as assigned (5%)
2 years regulatory affairs required
2 years oncology experience is preferred
Possesses up to date knowledge of the profession and industry; accesses and uses other expert resources when appropriate
Discretionary decision-making and independent judgment skills
Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines
Must be precise, thorough, reliable, and perform daily activities with minimal supervision
Knowledge of clinical research process and regulations
Demonstrated analytical skills; ability to create ad hoc reports, tracking tools, and professional documents; and the ability to interpret and apply complex government regulations

124

Compliance & Regulatory Specialist Resume Examples & Samples

Ensures and monitors compliance with all federal, state and local regulations while advising management of pending legislation and regulatory changes that will impact the company
Serves as subject matter expert for licensing requirements and ensures locations and employees are in compliance with federal, state and local law
Assists with the mediation of regulatory concerns and representing the company interests when necessary
Seeks to proactively resolve compliance issues
Performs audits for compliance with regulatory and third party audit standards and provides timely report findings
Partners with members of service, technical and training teams to ensure compliance with federal, state and local regulations
Serves as liaison with state regulatory and pest control associations
Works with branch, customer center, or Service Quality Managers to ensure proper licenses or certifications are assigned to each employee as defined by company policy and regulations
Maintains standards for license requirements, verifiable documentation and updates/communicates requirements to field management as needed
Close visual acuity to perform detail oriented activities at distances close to the eyes, as well as visual acuity to perform activities at or within arm’s reach with skill, control, and accuracy, such as preparing and analyzing data, viewing computer screen and expansive reading

125

Product Regulatory Specialist Asia Resume Examples & Samples

Ensures and supports product stewardship activities which adhere to the AkzoNobel corporate standard and other relevant standards such as Responsible Care®
Participates AkzoNobel networks and working groups as appropriate for the role
M. Sc in Chemistry or Chemical Engineering or related field
Fluent English, and prefer fluent Japanese language
5 - 7 years relevant experience
Broad background in product regulations, hazard communication and product stewardship
Ability to build up a network being service oriented, organized, flexible and reliable
Change agent

126

Real Estate Regulatory Specialist Resume Examples & Samples

Managing the vendors and processes to acquire new sites, do site additions and modifications, and co-locations
Coordinate any FCC/FAA/NEPA/SHPO Filings to HQ Regulatory team
Review applicable Land Use and Zoning Ordinances,
Negotiating Lease agreement terms and conditions with potential landlords and facilitating signature of same
Negotiate & Process Lease Amendments for new sites and site modifications such as antenna changes, generator additions, and equipment expansions
Work closely with Zoning Team to help formulate the strategy attached to a specific Land Use application (for a Search Area), including, but not limited to, selection of expert witnesses, preparation for Planning or Zoning Board Hearing and creation of requisite exhibits
Enter required information into HQ/Regional databases, including Siterra, Site Tracker, Netsites, EMIS, and Rent Commencement to ensure accuracy
Review vendor invoices applicable to assigned Search Areas and forward on to Real Estate Manager for approval
Understand department budgets to ensure region is adhering to spending goals including compiling monthly spending target from vendors
Coordinate Special events within the Region including the deployment of Cell on Wheels
Coordinate and support Sales initiated projects, including coordinating engineering/environmental site surveys in order to develop coverage solutions and working with the Sales and Construction team to provide estimated cost information and negotiating the agreements
Coordinate In-Bound In-Building Co-location applications. Ensuring application accuracy and working on providing costs and finalizing agreements with wireless carriers

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