Regulatory Associate Resume Samples
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Regulatory Associate Resume Samples
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JK
J Kutch
Joseph
Kutch
6887 Mills Locks
Houston
TX
+1 (555) 785 8999
6887 Mills Locks
Houston
TX
Phone
p
+1 (555) 785 8999
Experience
Experience
Los Angeles, CA
Regulatory Associate
Los Angeles, CA
Kessler, Parker and Gutmann
Los Angeles, CA
Regulatory Associate
- Providing central regulatory sign off for all Kellogg Europe snacks and cereal artworks
- Works with portfolio managers, traders, wealth advisors, operations, finance, marketing, and other associates to identify and resolve compliance issues
- Participate in weekly NPD (New Product Development) meetings to discuss/develop regulatory strategies and state timing for all current and future projects
- 3.2 Edit work, as directed. Responsible for quality of own work
- Assists in the review and update of standard operating procedures and work instructions for regulatory processes
- Perform other related duties incidental to the work described herein
- Assist/Manage the stop sale process and the state sales restriction process (from the department’s view)
Los Angeles, CA
Regulatory Associate Manager
Los Angeles, CA
Boyer-Littel
Los Angeles, CA
Regulatory Associate Manager
- Manage internal nutrient database by assuring robust nutrient data from suppliers, USDA and chemical analysis
- Collaborate with product developers to evaluate supplier data for new or novel ingredients
- Develops timelines for submissions, expected approvals, and prioritization under the directions of Regulatory Head
- Develop international technical data document process and database for International Logistics and Export teams
- Create Nutrition Facts Panels and ingredient lines for all products
- Orchestrate nutrition analytical testing, sample submission and documentation management
- Provide consumer-facing label reviews and guide Creative team on label design
present
Boston, MA
Senior Regulatory Associate
Boston, MA
Mraz-Pfannerstill
present
Boston, MA
Senior Regulatory Associate
present
- Team Work & Sharing Best Practice
- Interface with Government Officials for company matters and/or improvement in regulations
- Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed. Understands stakeholder timelines and objectives
- Represent the company in Industry Associations, especially in technical discussions aiming to improve the Regulatory environment
- Biotech traits registration; new breading technics advocacy work for regulatory determination; regulated material permitting; compliance with regulations; internal audits and trainings; official reports; post-commercial monitoring activities. Corn hybrids and sorghum varieties registration
- Apply Microsoft Office programs and RB Systems relevant to area of responsibility to deliver against project strategy. Utilize online resources and programs to navigate key external agency and trade association web sites. Responsible for authoring and reviewing multiple and more complex departmental SOP/work practices
- Develop and communicate submission strategies to the cross-functional project team
Education
Education
Bachelor’s Degree in Customer Service
Bachelor’s Degree in Customer Service
Howard University
Bachelor’s Degree in Customer Service
Skills
Skills
- Detail-oriented and possesses strong organizational/planning skills and the ability to prioritize multiple tasks/projects
- Knowledge of Agency submission procedures and practices. Knowledge I awareness of emerging submission electronic standards
- Strong Regulatory Reporting knowledge, including experience with FR Y9C, Call Report, FFIEC 009, etc
- Strong attention to detail and accuracy
- Knowledgeable with MS Office and Outlook
- Strong attention to detail
- Excellent Microsoft Excel knowledge
- Strong regulatory reporting knowledge, including experience with FR Y9C, Call Report, FFIEC 009, etc
- Ability to build and maintain professional relationships with internal team members and other departments
- Ability to function independently within a team to build strong relationships with multiple groups
15 Regulatory Associate resume templates
Read our complete resume writing guides
1
Financial Services Regulatory Associate Resume Examples & Samples
- A minimum 2.2 degree in any discipline, at least 300 (24) UCAS points, a grade B or above for GCSE Mathematics and English Language (or equivalent)
- Inquisitive and analytical thinking
- Enthusiasm to face new challenges and learn new skills
2
Regulatory Associate Resume Examples & Samples
- Conducts research in order to interpret new and existing regulations as mandated, including, but not limited to, changes to regulatory requirements and SEC examination focus items
- Assists with preparation for and communication with regulatory agencies including, responding to inquiries, maintaining records/documentation and preparing for audits
- Prepares and submits required reporting for regulatory bodies (SEC and state regulators) including, but not limited to, Form ADV, 13-F and 13-Gs
- Works with portfolio managers, traders, wealth advisors, operations, finance, marketing, and other associates to identify and resolve compliance issues
- Maintains Code of Ethics and Policies & Procedures manuals
- Responsible for training and updating personnel on compliance issues, including through annual compliance meetings
- Reviews all responses to Requests for Proposals; reviews all marketing presentations to potential clients in an editorial capacity and to ensure compliance with regulatory requirements and disclosures
- Works with manager and team members to continually enhance the effectiveness of the overall compliance program
- Conducts, at least annually, a complete compliance review of all policies and procedures and keeps accurate detail of all audits including forensic testing of files
- Identifies deficiencies in compliance processes and procedures that may lead to internal and/or regulatory non-compliance and assists with resolving any deficiencies and/or issues found
- Attends and prepares for quarterly Best Practices/Compliance Committee meetings including report preparation, agenda preparation, scheduling and file maintenance; maintains best execution files; maintains error files
- Assumes additional responsibilities and special projects as needed
- In depth knowledge and experience, or ability to quickly gain requisite knowledge, of SEC laws, industry practice, policies and their application and other regulatory requirements relating to investment advisers, including the Investment Advisers Act of 1940
- Proactive problem solving, strong analytical skills, critical thinking abilities
- Ability to tell when something is wrong or is likely to go wrong; to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems; to combine pieces of information to form general rules or conclusions, considering the implications of all options (benefits, costs and risk factors) and being able to determine the most appropriate solution
- Experience with process and project management and implementation
- Multi-tasking and prioritization of duties
- Extremely strong written, oral and interpersonal communication skills
- Strong editing skills
- Ability to build and maintain professional relationships with internal team members and other departments
- Ability to work under deadlines and at a rapid pace
- Law degree or anticipated law degree
- Investment advisory compliance experience, direct federal and/or state regulatory experience preferred; or related clerk and internship experience coupled with advanced education
- Knowledge of business and management principles involved in strategic planning, resource allocation, leadership technique, production methods and coordination of people and resources preferred
- Experience with compliance monitoring technology, processes and systems, including processes to make improvements or take corrective action, within a registered advisory firm
3
Regulatory Associate Resume Examples & Samples
- 5+ years of Regulatory Submissions experience
- Bachelor's Degree in related field
- Hands-on experience with all modules of eCTD
- Experience with regulatory files/documents and familiarity with R&D documentation (e.g. "content" documents such as CMC, Nonclinical, Clinical, for inclusion in regulatory submissions)
- Previous experience with tracking regulatory submissions, annual reporting needs and global regulatory approvals (pre- and post- marketing)
- Proficiency with Microsoft Office Suite (Word, Excel) and Adobe
- Solid analytical and problem-solving skills
- Life Sciences experience
- Electronic Document Management System (EDMS) experience
- Experience with Veeva Vault
- Prior interaction with eCTD vendors
4
Regulatory Associate Resume Examples & Samples
- 1+ year of relevant accounting experience
- Strong data aggregation skills
- Excellent Microsoft Excel knowledge
- Strong understanding of US GAAP
- Experience in databases and systems
5
Regulatory Associate Resume Examples & Samples
- 6+ years of relevant Accounting experience
- Good understanding of US GAAP
- Strong Regulatory Reporting knowledge, including experience with FR Y9C, Call Report, FFIEC 009, etc
- Microsoft Excel proficient
- Working knowledge of PeopleSoft / Hyperion
6
Public Policy / Regulatory Associate Resume Examples & Samples
- Participating in short- and long-term engagements to support federal clients whose responsibilities are to develop policies and craft regulations that implement a desired policy, explain the rationale of the rulemaking to interested parties; and implement the regulatory requirements
- Immersing oneself in varied projects for multiple clients
- Leading project teams
- Assisting senior managers on business development
- Master's degree in business administration, economics, environmental management, law, natural or physical science, government, public administration, public policy, urban planning, or related subjects
- Minimum GPA of 3.0
- Understanding the Federal regulatory development process, including key executive orders and OMB orders and circulars
- Proficiency in MS Office (Word, Excel, PowerPoint)
- Security clearances that have been active within the last 24 months
- Excellent verbal, interpersonal, and written communication skills
- Strong analytical, problem-solving, and decision making capabilities
- Ability to prioritize and work on multiple projects under strict deadlines in a fast-paced environment
7
Capital Markets Regulatory Associate Resume Examples & Samples
- Product & Process
- Risk & Control
- Other key attributes include excellent communication skills with a strong client focus and the ability to communicate with a variety of individuals at various levels within the bank
- Undergraduate degree in finance, business, economics, applied mathematics, statistics or science required
- Progression towards or interest in post-graduate designations or degrees would be a bonus (CFA, MBA)
- 3 to 5+ years of Capital Markets Trading experience required
- Familiar understanding of the banking industry standards for reference data (e.g., ISO standards, Bloomberg, Reuters)
- Experience or knowledge in General Ledger and basic principles of reconciliation and reporting lines on financial statements is an asset
- Experience or knowledge of the business unit’s key products and services
- Knowledge of departmental systems and applications, earned through internship or entry level positions
8
Regulatory Associate Resume Examples & Samples
- Assists in managing various aspects of the Regulatory Exam Management Program
- Participates in additional projects and ad hoc reporting as requested
- Contributes to Risk Management projects and initiatives
- Participates and volunteers for continuous improvement projects
- Provides back-up to Regulatory Liaison , or other associates as needed
- Education and experience
9
Regulatory Associate Manager Resume Examples & Samples
- Provides regulatory advices to project teams according to local regulations/requirements
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
- Develops timelines for submissions, expected approvals, and prioritization under the directions of Regulatory Head
- Coordinates, compiles and submits new drug applications to the regulatory agency
- Organizes and maintains reporting schedules for new drug applications
- Prepares scientific responses to regulatory agency questions and other correspondences
- Collaborates with local cross-functions team and regional/global regulatory team
- Provides solutions to extreme complex problems in which data analyses requires an evaluation of intangible variables
- Bachelor / Master Degree from reputable university
- Min. 4 years experience in related background
- Experienced in pharmacy company would be preferred
- Experienced in handling new product registration
- Fluent in English both oral or written
10
Regulatory Associate Resume Examples & Samples
- The candidatewill assist the HERS NA Chemicals Group (CG) and Food Contact (FC) group incompleting various notifications and regulatory reporting requirements forintertek clients. This includes chemicalformulation and compliance requirement reviews, data entry, review ofanalytical data, preparation of safety and hazard communication documents, liaisonwith clients, customers and suppliers, preparing dossiers and data input intovarious regulatory reporting software, etc
- The role is designated as a part time role based on a20 hr/wk time commitment and will be remunerated based on worked hours enteredinto a timesheet for approval by the Senior Director, Chemicals Group
- Additional worked hours above and beyond 20 hr/weekwill be compensated at the agreed hourly rate but hours worked cannot exceed 40 hr/week
- To critically review relevant information toformulate assessments and to draw scientific conclusions
- To assist in the implementation of regulatorystrategies for the pre-manufacture/pre-import notification of industrial,commercial and consumer chemicals
- To assistin the development and delivery of hazard communication advice and relateddocuments
- The candidate will conduct chemical reviews andreporting as directed by Senior Director, Chemicals Group and VP Regulatory(US). This work will be done in accordance with defined scopes of works and timelines
- The candidate will be a shared resource between thedifferent Project Managers and Sr. Technical Experts within the CG and FCgroups but will report to the management structure detailed in #4 below
- Scientific Tasks:Gather, review and interpret scientific,regulatory and/or client business-related information
- 1. Gather, review and interpret informationobtained via published and unpublished literature, from the client, fromsubcontracted testing laboratories and/or provided by project managers
- 2. Use own initiative to make sure that selectedmaterials are complete and adequately address the data gap
- 3. Summarize and extract relevant information
- 4. Keep track of reference materials
- 5. Classify ingredients according to relevanthazcom regulations
- 6. Present summarized information, or hazcomdocuments, to project manager for review
- 7. Edit documents as required based on projectmanager’s review
- 8. Address concerns and questions of the projectmanager in relation to the material accumulated on the project
- 9. Ensure timely response to all queries andthat all responses have the appropriate information and signage
- Regulatory Tasks: Compiling RegulatoryNotifications and Preparation of Regulatory Documents
- 1. Learn regulatory issues related to HPA, CPR,NSNR and related government programs, accomplished through reading governmentdocuments, journal articles, assessment of government regulations and attendingworkshops and/or conferences and general communication with senior staff
- 2. Discuss and understand the notification/hazcomstrategies outlined in project proposals authored by senior staff
- 3. Work with project manager to gather requiredinformation (see above)
- 4. Review information to ensure adequacy fornotification/hazcom purposes
- 5. Compile and summarize administrative/technicalexposure-related information into the prescribed format, depending ongovernment requirements (with assistance from administrative support staff, andothers, where required)
- 6. Submit draft notifications/hazcom documents intoto to project manager for QA/QC and technical review
- 7. Edit, as required
- 3 General Project Coordination, as requested
- 1 Prepare project promotional packages, assistin the identification and distribution of necessary tasks
- 2 Edit work, as directed. Responsible for quality of own work
- 3 Remain in contact with team, e.g.,word processors, outside printing companies, etc. to ensure the scope ofwork remains focused and within the financial budget and time line allocated tothe project
- 4 Delegate final documents to word processingfor formatting and editing and delegating and coordinating copying and bindingfrom external subcontractors, where needed
- 5 At the incumbent’s discretion, delegateadministrative tasks to library and word processing (e.g., inter‑officeinquiries and maintenance of the corporate marketing, international regulatory andproject management databases)
- 4 Responsible for quality of own work
- The candidate will work both independently and withinteam settings based on the assigned tasks. The candidate must be self motivatedand self regulating in order to ensure efficiency and autonomy
- Science/Chemical Degree (B.Sc.), or equivalent collegeprogram, required
- 2-5 years of experience in an international consultingenvironment
- Ability to process information, followdirections, create/edit reports with some guidance; interpret data
- Aptitude and interest in regulatoryscientific issues
- Ability to multitask and effectivelyprioritize
- Communications skills (oral and written)
- Versatility - multi-tasking (ability tohandle many different tasks simultaneously)
- Teamplayer
- Workingknowledge of various word processing and graphic software packages
11
Senior Regulatory Associate Resume Examples & Samples
- Supporting all regulatory activities associated with the development, post-approval and life-cycle management for designated products within the Oncology portfolio
- Providing regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate
- Providing guidance and support to product development teams on regulatory issues
- Contributing to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results
- Excellent relationship building skills with the ability to communicate at all levels
- Knowledge of how Health Authorities operates and a good general knowledge of HA organizational structure and individual responsibilities in those structures
- Ready to apply our knowledge and know-how
- The drivers of our own success
12
Regulatory Associate Resume Examples & Samples
- Bachelor's Degree in a scientific or health sciences discipline preferred (e.g. pharmacy, chemistry, biochemistry or related scientific discipline)
- Three to five years manufacturing or manufacturing support role experience or one to three years regulatory experience
- Knowledge of Agency submission procedures and practices. Knowledge I awareness of emerging submission electronic standards
- Certificate in Industrial Pharmacy with an emphasis on Regulatory
- Demonstrated negotiation and influence skills
- Demonstrated expertise and skill set tor publishing complex CMC submissions, including global CTA and/or CTD submissions using Leo and eCTDXpress publishing systems
- Demonstrated ability to effectively prioritize and manage competing priorities and responsibilities
13
Technology Transfer & CMC Regulatory Associate Resume Examples & Samples
- Assist with managing multiple complex technology transfer projects related to the manufacturing and testing of Avid products
- Maintain clinical trial CMO sites within defined regions to ensure reliable manufacturing and dose delivery
- Communicate with CMO sites, vendors, and internal groups regarding technical and compliance issues, timelines, and data
- Ensure CMO sites are in compliance with manufacturing, testing procedures, specifications, and applicable regulatory documents
- Review qualification documents and batch records and identify errors and trends
- Identify suppliers and raw materials requirements associated with process transfer
- Complete documentation and verification associated with technology transfer process
- Collaborate with Assistant Director to develop timelines and resolution to issues
- Author and review technical documents including standard operating procedures, testing protocols, technical reports, batch files, and technical transfer documents
- Develop working knowledge of Avid Radiopharmaceuticals’ manufacturing and analytical procedures and method validations
- Develop a thorough understanding of Avid’s Chemistry, Manufacturing, and Controls (CMC) regulatory filings and manufacturing and analytical procedures
- Assist in writing Avid’s CMC regulatory documents
- B.S. in Chemistry or related field
- A minimum of 2 years of pharmaceutical industry experience
- PET drug experience is desirable
- Understanding of cGMPs desirable
- Extremely high attention to detail
- Strong desire to work independently and within a team in a highly focused manner
- Impeccable organizational skills
- Superior written and verbal communication skills
14
Regulatory Associate Resume Examples & Samples
- Incoming correspondence and records of contact
- Serve as the GRA-US operational lead for IND and NDA registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings and GRA/CRR planning
- Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER , routine maintenance submissions
- Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation process, product withdrawal process
- Provide registration management expertise to the due diligence and business development processes
- Serve as the registration management expert for other processes dependent upon the registration record (e.g. DSI requests, out-license, user fees/drug listing/orange book)
- Develop collaborative relationships with personnel in other Lilly functional areas (e.g. medical, legal, labeling, compliance, quality etc.) to effectively influence the electronic registration plan
- Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutions
- Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of the Agency’s internal process and requirements to optimize the application presentation to facilitate review
- Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings
- Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise
- Influence others in a manner that creates maximum advantage for the organization
- Communicate verbally and in writing to effectively influence within work group/function and with development team
- Bachelor’s Degree. Scientific or health sciences discipline preferred (e.g. pharmacy, nursing, chemistry or related scientific discipline)
- Demonstrated ability operate and manage operational requirements in a highly regulated environment
- Demonstrated effective written, spoken and presentation communication
- Demonstrated effective negotiation and influence skills
15
Graduate Regulatory Associate Resume Examples & Samples
- Providing hazard communication information on our chemical and hygiene products, including Safety Data Sheets
- Learning the processes for the safe introduction of new products
- Participating in technical meetings of product safety issues
- Liaising with our regional and global regulatory teams
- Participating in cross-functional projects, representing the regulatory function
- Understanding and communicating hazards and how they impact the movement of chemicals
- Bachelor’s degree in Chemistry preferred, or a related Science
- Excellent computer skills in MS Office. SAP experience a bonus
- Strong attention to detail and calm under pressure
- The ability to understand technical information
- A willingness to learn business and regulatory processes
- The ability to work both autonomously and with a team
- High commitment to Safety, Environment, Occupational Health and Quality
16
Regulatory Associate CMC Resume Examples & Samples
- Bachelor's Degree. Scientific or health sciences discipline preferred (e.g. pharmacy, nursing, chemistry or related scientific discipline)
- 1-3 years of regulatory experience
- Industry-related experience
- Knowledge of drug development process, Lilly regulatory/business strategies and plans
- Demonstrated ability to operate and manage operational requirements in a regulated environment
- Demonstrated written, spoken and presentation communication
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
- Combination of industry/regulatory business and/or technical knowledge and skills developed through education and past experience
17
Regulatory Associate Resume Examples & Samples
- Assists with preparation and submission of marketing authorisation variations according to government acts and regulations
- Assists with preparation of regulatory submission documents including Investigational Medicinal Product Dossier (IMPDs) and varying Modules of the Common Technical Document (CTD) when applicable
- Assists with coordination of project administration
- Coordinates and develops the Table of Contents for submissions
- Performs quality checks on related documents
- Assists with submissions of other regulatory documents as needed
- Composes detailed or confidential correspondence
- Assists clients, customers, or others with general information
- Gathers, compiles, analyzes, and reports information
- Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence
18
Global Regulatory Associate Director Resume Examples & Samples
- Manage a complex and diverse set of registration/regulatory requirements across multiple markets to enable strategic global pipeline delivery
- Strategic leadership of global consumer product development and registration projects for their category to meet the business objectives
- Develop and deliver innovative global regulatory strategies in their category
- Bias towards strategic vision, views & articulation with a credible foundation of delivery
- Ability to translate complex regulatory information into a compelling stakeholder friendly language
- Work collaboratively with team in order to define and implement the regulatory strategy
- Work collaboratively within R&D community to define global registration dossiers and technical documentation
- Provide regulatory strategy assessments of internal and external commercial opportunities in concert with appropriate technical and regional/local regulatory input
- Working with LRA, support and where necessary lead Health Authority meetings/negotiations in support of submission and approval of strategic new product registrations in critical markets
- Work in partnership with the local regulatory teams to identify and be aware of key requirements and that they are taken into account to deliver a ‘right first time’ approach to new product development
- Influence externally where appropriate industry led regulatory reviews and initiatives of direct relevance to RB, in-line with RB’s strategic vision
- Take the regulatory lead in the preparation of responses to address significant safety ,regulatory and PR issues in the assigned Category
- Support internal investigations into allegations of non-compliance
- Devise, and deliver to business partners, training materials that optimally prepare the business for the present and future regulatory environment
- Ensure through dynamic resourcing that appropriate support is given to the Innovation projects & team
- Responsible for delivery of dossier/technical file to agreed time frames and collaborate across partner functions to ensure timely deliver of all information required, to enable robust and consistent project updates
- Supports work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market
- Educated to honours degree level in a scientific field or equivalent experience
- Relevant Regulatory Experience and knowledge in NPD and dossier/technical file creation and global registrations
- Experience in different regulatory classifications (where appropriate) Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration
- Experience in preparing and submitting dossiers, variations and renewals
- Ability to communicate requirements
- Understanding of global product development practice, rules, regulations and guidelines
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries
- High level of accuracy in reviewing and authoring documentation
- Ability to consistently deliver to time, cost and quality standards in a high pressure environment
- Knowledge of submission processes and product life cycle management activities for various consumer product categories
19
Global Regulatory Associate Post Approval Maintenance Resume Examples & Samples
- A self-starter you are results orientated and have a collaborative approach
- Proven ability to manage numerous projects to deliver on time
- Understanding of R&D and/or regulatory
- Experience of working in a regulatory or R&D setting
20
Global Regulatory Associate Resume Examples & Samples
- Work in partnership with the local regulatory teams to identify key regulatory requirements for projects and business initiatives covering cosmetics, biocides, medicines and medical device products
- Responsible for delivery of regulatory dossier/technical files to agreed time frames
- Collaborate across partner business functions to ensure timely delivery and robust and consistent project updates
- Responsible for project management of regulatory project requirements & dossier/technical file creation in line with the project strategies
- Support internal compliance activities and initiatives to ensure regulatory compliance throughout the globe
- Bachelor’s Degree in a scientific field or equivalent; relevant industry experience. Preferred
- Awareness of regulatory requirements in dossier/technical file creation and global registrations preferably covering cosmetics, biocide, medicines or medical device products
21
Global Regulatory Associate Post Approval Maintenance Resume Examples & Samples
- Minimum 2 years’ experience of working with medical devices in either a regulatory, quality or R&D setting
- Understanding of EU medical device landscape
- Experience in ingredient removal programmes in cosmetic products
- Experience of collation of dossiers and data packages
- Understanding of global medical device regulations
22
Wireless Regulatory Associate Resume Examples & Samples
- Assists with the coordination of the pre and post-construction environmental compliance process for assigned projects
- Monitors compliance in regards to FAA/FCC guidelines for RF Exposure Safety and National Environmental Protection Act (NEPA). Completes summary of scope of work and summary of existing environmental and NEPA reports
- Monitors and tracks progress on all open compliance transactions. Receives third-party vendor deliverables. Ensures compliance to the quality and safety goals and objectives
- Coordinates Pre and Post Construction environmental compliance process for assigned projects
- Monitors compliance in regards to FAA/FCC guidelines for RF Exposure Safety and NEPA / SHPO
- Retrieves and reviews Phase 1 environmental reports against proposed scope of work for compliance requirements
- Communicates activities with team members, and other departments as needed
- Orders applicable Compliance documents per FAA/FCC, RF Safety and Client guidelines
- Coordinates purchase orders / financial approval for scope of work
- Receives 3rd party vendor deliverables
- Coordinates with Construction team for implementation of required Notices and Postings on site
- Performs updates of Client Regulatory Databases
- Performs upload of Compliance Deliverables to Siterra as requested by Client
- Provides Compliance Deliverables to Close Out team, as applicable
- Updates internal company databases as required
- Provides status reports to Compliance Manager and reviews and approves site specific documents. Reviews the quality and completeness of site specific documentation
- Monitors and tracks progress on all open transactions
- Maintains a high degree of customer service and integrity when dealing with clients
- Associate degree, or equivalent work experience
- Minimum of one year experience in the telecommunications industry, tower industry, and environmental reporting are highly preferred
- Real estate, sales, or legal negotiation experience strongly desired
- Proficiency in Microsoft Excel, Word, and Outlook
- Adheres to, supports and enhances the Divisions Environmental, Safety, Health and Security Program and enhances the Divisions Quality Management System
- Keyboarding, Sitting, Some limited travel for site visits
23
Commercial Regulatory Associate Resume Examples & Samples
- Train organization and vendors on CRC Process and PMRC Process, including the review and approval of materials through electronic review system
- Ensure adherence to CRC and PMRC SWP; Oversee and manage the review and approval process for CRC and PMRC materials
- Collaborate with Material owners and Commercial Regulatory reviewer to set realistic agendas and ensure the timely distribution of agenda and materials; Review materials submitted for CRC and PMRC review to determine appropriateness and completeness prior to scheduling CRC and PMRC meeting
- Support Material owner with facilitation of CRC and PMRC meetings and capture of reviewer comments
- As needed, act as a liaison with vendors to ensure incorporation of CRC and PMRC comments
- Assist Commercial Regulatory reviewer with review of resubmitted pieces and final flats and ensure all requested changes have been incorporated; Manage proof reading process of promotional items prior to release to printer and submission to FDA as needed
- Prepare CRC approved materials for submission to FDA on Form 2253 at time of first use
- Bachelor’s Degree with pharmaceutical industry work experience (2-3 years) preferred
- Excellent written and oral communication skills including ability to train and present effectively
- Attention to detail (including proof reading skills)
- Process orientation and management is critical
- Experience in vendor management
- Documentation and recordkeeping skills
- Microsoft Office, including Excel, Word and PowerPoint
24
Regulatory Associate Resume Examples & Samples
- Prepare regulatory documents for new study submissions to IRB and sponsor
- Maintain regulatory files at audit-ready status at all times by ensuring filing are up-to-date upon completion of the processing of new or revised documents
- Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements
- Receive, track, and distribute IND Safety Reports to the Principal Investigator for acknowledgement of review and file. Submit IND Safety Reports to the study-assigned IRB if submission is not handled by the sponsor
- Inform clinical operations of new study approvals including at initiation, amendments, and consent forms upon receipt. Ensure documents are distributed to the clinical team as appropriate and filed
- Communicate and update Sponsor with any revised site information and notify the IRB as required
- Liaison with IRBs on a frequent basis to ensure resolution of outstanding submissions requests
- Learn and utilize IRB electronic web portals for the processing of study submissions
- Distribute IRB feedback on new study submission to the clinical team and sponsor for resolution of questions or Board requests
- Manage the development of new Informed Consent Form drafts with the IRB, as needed, and ensure agreement with ICF language between Compass Clinical Operations teams, IRB, and Sponsor
- Obtain Clinical assignments from the Operations teams for the development of new Delegation of Authority Logs and inform teams of missing information or needs for updates to the Logs
- Verify protocol training is captured and returned to the regulatory department prior to the assigned staff members completing the Delegation of Authority Logs
- Ensure all regulatory books are updated at final monitoring closeout visits
- Inform assigned individuals of the need for archiving assistance of closed regulatory books at the defined time frame for long-term storage
- Liaison with sponsor monitors during routine and closeout monitoring visits to ensure resolution of outstanding regulatory document requirements are attended to within an appropriate time frame
- Schedule monitoring visits, prep books, and assign monitoring space as requested
- Provide team assistance on all projects as needed
- Assist in the tracking of the status of new study submissions status
- Perform ad-hoc projects and/or general office duties as necessary
- Learn and support the organization goals, missions, and values
- Good interpersonal, planning/organizational, and communication skills (written and oral)
- Ability to handle multiple tasks/projects simultaneously
- Handles confidential information appropriately
- Takes initiative and participates as a team player
- Knowledgeable with MS Office and Outlook
- Associate’s Degree required
- Minimum 1 year of research experience required
25
Regulatory Associate Resume Examples & Samples
- Maintain current understanding of key relevant Regulatory requirements and processes in the countries in which ClinicalRM may operate.Provide guidance on identification and interpretation of the governing regulations and requirements
- Ensure successful delivery of contract deliverables
- Monitor, track, and report regulatory trends and global improvement opportunities to senior management. Develop SOPs in support of implementation and compliance with regulations
- Provide support and input for product development. Interface with relevant regulatory agencies. Responsible for regulatory submissions and ongoing reporting requirements to the FDA and local government regulatory agencies outside of the US
- Review, generate, complete, track and file key regulatory documents. Create and submit regulatory progress reports. Ensure maintenance of regulatory files of all regulatory submissions and approvals
- Review, record findings, and make recommendations for regulatory and other critical documents for completeness, accuracy, and consistency with established guidelines. Provide final approval on all submitted documents, as relevant
- Correspond and communicate (via telephone, e-mail, or fax) with Sponsors, Investigators and regulatory entities as required to provide information or updates on regulatory issues
- Provide support and backup for other QM functions. As needed, help manage internal/external audits and regulatory inspections. Perform other quality assurance and quality control functions as necessary
- Participate in operations meetings to appraise team with the status of ongoing regulatory activities
- Liaise with business development to identify new opportunities, develop customer relationships, perform capture management, and participate in proposal development
- Attend study team meetings
- Assist with training of new personnel as directed
- Perform other related duties incidental to the work described herein
- Maintains a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
- Performs light duties and other related duties as required and assigned
- Bachelor's degree (B.S.) from a four-year college or university in a technical, business, sciences or related field. Advanced degree preferred
- 8-10 years of experience in Clinical Research industry with a minimum of 5-7 years supervisory/management experience in regulatory or quality and regulatory
- Current knowledge of FDA and international quality system regulations required
- Specific experience developing regulatory submission strategies
- Knowledgeable in project planning; Regulatory/Ethics submissions for all phases of clinical trials; knowledge of GCP/ICH
- Must be able to work independently following a brief period of specific technical training
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Financial Services Regulatory Associate Resume Examples & Samples
- 2+ years’ of experience in a law firm or government setting working with regulatory and administrative law
- U.S. JD, with U.S. bar membership and ability to be admitted to the Washington, DC Bar via waiver
- Excellent law school credentials and grades
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Senior Regulatory Associate Resume Examples & Samples
- Completion of assigned tasks with a high level of quality within departmental and company timelines
- Understand and learn the art of regulatory review of promotional materials
- Other duties as assigned, which may include assisting other functional areas within regulatory affairs, on an as needed basis
- BA/BS degree or equivalent experience in related field preferred
- 1-3+ years of experience working in regulatory affairs ideally with exposure to advertising, promotion, and labeling
- Familiarity with FDA regulations and guidance rules as they pertain to labeling and advertising & promotion preferred
- Excellent attention to detail (including proofreading skills)
- Outstanding interpersonal and effective task planning / coordination skills
- Strong teamwork, negotiation and influencing skills
- Advanced skills in using Microsoft Office Word and Adobe programs
- Comprehension: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints
- Decision Making: Ability to make decisions which have impact on the department’s credibility, operations, and services
- Communication: Ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications of major scope and impact, etc and to make formal presentations
- Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes
- Ability to learn on the go and obtain the skills needed to work within a technical environment
- Strong communication and organization skills with attention to detail (including proofreading skills)
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Manufacturing Site CMC Regulatory Associate x Resume Examples & Samples
- The candidate must possess a degree in science with a minimum of 4 years of experience in the pharmaceutical industry
- The ideal candidate will have experience in Regulatory Affairs for manufacturing site, with a focus on Regulatory CMC requirements for Marketed small molecule/biologic products, development, manufacturing and/or quality assurance
- He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks
- Must have a proven ability to communicate effectively in both a written and verbal format. The ideal candidate will be fluent in 1-2 languages spoken in the region of responsibility, in addition to English
- Ability to influence and work both independently and collaboratively in a team structure
- Proven ability to work well under pressure
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Wireless Regulatory Associate Resume Examples & Samples
- Updates internal databases as required
- Provides status reports to Compliance Manager
- Reviews and approves site specific documents
- Reviews the quality and completeness of site specific documentation
- Individual contributor with no subordinates
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Regulatory Associate Director Resume Examples & Samples
- Plays a lead role in staying current with the regulatory landscape as it pertains to a central lab. Areas include but not limited to CDx, Dx, genomics and vaccines
- Interprets, assesses gaps with and assists the appropriate functional teams in modifying existing or creating new procedures and processes based on changes in regulations
- Identifies gaps in regulatory compliance and provides ways to mitigate risks as appropriate
- Designs and delivers training as necessary to enhance regulatory awareness throughout the organization
- Work with the QA colleagues to ensure that global QA audit practices remain current with the regulatory requirements
- Enhances Covance’s external profile, and develops an effective network, through active participation in external industry and regulatory forums
- At least 10 years’ experience in a CAP/CLIA, GxP-regulated environment
- Clinical Trial Lab experience
- Quality Assurance experience
- Experience with Bioanalytical Assays is preferred
31
Legal & Regulatory Associate Resume Examples & Samples
- Provide legal support based in NY for Aflac Global Investments activity, with a focus on corporate finance and derivatives
- Provide legal advice to the credit, trading, portfolio management and operations teams in the US and Japan regarding terms and documentation of institutional investments and derivatives
- Assist credit and portfolio management teams with assessment of transaction terms and corporate group structures, and with amendments, consents and special situations
- Negotiate credit and derivatives documents, including note purchase agreements, indentures, trust deeds, loan agreements, ISDAs, CSAs, Futures Agreements, and related amendments and consents
- Advise credit team on financial covenants, structured investments vehicles such as repackaged investment trusts, reverse dual currency instruments, complex financing transactions, and restructuring matters
- Monitor and advise business teams on regulatory developments related to derivatives, including relevant provisions of the Dodd-Frank Act, CEA, and EMIR
- Provide support to investment and operations teams in US and Japan on derivatives operational issues such as collateral movement and valuation
- Oversee external counsel providing support on the foregoing matters
- Work closely with Aflac Global Investments Compliance personnel, and provide legal support and advice on certain transactional and derivatives matters to Compliance personnel
- Monitor developments with the NAIC, SEC, Japan FSA, State DOI’s, and CFTC as they relate to the Investment function
- Provide guidance on permissible investment and transaction-related activities
- Work to limit regulatory and reputational risk of Aflac and help to reinforce Aflac Global Investment’s culture
- Assist in the preparation of management and committee reports
- 5+ years of experience in Corporate Finance and Derivatives - Insurance Industry experience a plus
- J.D., Admission to State Bar of New York, required
- Transactional experience drafting and negotiating documents for complex financing transactions and derivatives
- Able to take initiative, multi-task and work under pressure. Self-manage workloads
- Familiarity with cross-border finance
- Ability to work effectively across a global organization
- Understanding of US and Japan Securities and Derivatives Regulations as they pertain to Insurance Industry Investment activity
- Excellent analytical and research skills – ability to analyze a variety of legal issues and synthesize complex information. Strong attention to detail
- Ability to interface with all levels of management
- Ability to address conflicting requirements or points of view and facilitate compromise where appropriate
- Microsoft Office Suite (Excel, Access, PowerPoint, Word, Outlook)
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Regulatory Associate Resume Examples & Samples
- Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations
- Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use
- Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities
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Legal, Consumer Regulatory, Associate / VP Resume Examples & Samples
- Develop and review customer communication templates
- Monitor state and federal consumer finance developments with a primary focus on servicing and collections
- Assist business with filings in response to consumer bankruptcy process
- Work closely with business clients in dealing with and responding to consumers who engage third party debt managers
- Assist in the negotiation and management of key vendor relationships
- Assist in the development and management of disclosures and marketing claims
- Work with Compliance colleagues to facilitate remediation activities
- Opportunity to work closely with lawyers from other divisions regarding consumer finance transactions
- Knowledge of and experience with federal, state and local consumer finance laws and regulations including relating to servicing and collection, including the Fair Debt Collection Practice Act and state corollaries and laws and regulations prohibiting Unfair, Deceptive and Abusive Acts or Practices and state corollaries
- Knowledge of consent orders relating to marketing, servicing and collections
- Excellent attention to detail and strong organizational / project management skills
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Regulatory Associate Resume Examples & Samples
- Engage component and material manufacturers to obtain compliance statements pertaining to global regulatory requirements
- Analyze compliance statements which can include material declarations, certificate of compliance, test reports, etc
- Work hand-in-hand with Project Management to meet timelines and milestones
- Support Project Managers in customer meetings, calls, etc
- Work within internal systems to provide and solution issues with projects
- Perform other work as required
- Work well independently and as part of a team
- Excellent verbal and written communications
- Prefer web based computer program experience
- Excellent communication skills, in both verbal and written formats
- Microsoft Office proficiency, including Word, Excel, and Outlook
- Must have a proactive and positive attitude
- Ability to work independently in a fast-paced, multi-tasking environment with shifting priorities
- Ability to make timely decisions and problem-solve effectively with incomplete information under tight deadlines and pressure
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Senior Regulatory Associate Resume Examples & Samples
- Ability to interpret, apply, and implement regulations and guidances
- Share knowledge and experience with peers and cross functional team
- Solid knowledge of Canadian Regulatory Agencies. Applies gained knowledge and experience to increasingly complex regulatory issues. Shares knowledge and experience with peers
- Develop and communicate submission strategies to the cross-functional project team
- Oversee the preparation, review/approval, and dispatch of the regulatory submission. Responsible for coordinating responses to Regulatory Agency questions
- Attend trade association/Regulatory Agency meetings and may represent RB interests with key government agencies
- Apply Microsoft Office programs and RB Systems relevant to area of responsibility to deliver against project strategy. Utilize online resources and programs to navigate key external agency and trade association web sites. Responsible for authoring and reviewing multiple and more complex departmental SOP/work practices
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Regulatory Associate Resume Examples & Samples
- Exercises good judgment in developing and modifying methods/techniques for solving problems
- Completes projects of limited scope and/or portions of larger projects
- Works with clinical investigators and other clinical staff
- Assists with coordination of activities pertaining to the compilation and submission of original IND applications for management and multi-disciplinary team review
- Requests, compiles, and reviews documentation for IND/IDE/ DMF amendments, annual reports, safety reports, and other submissions required for the life-cycle maintenance of these applications
- Researches reports, regulations, guidelines, databases, internal policies, etc., as appropriate in response to regulatory inquiries from internal and external sources
- Collects and reviews study specific documentation for each protocol submitted under an IND/IDE
- Assists with preparation and/or updates of Investigator's Brochures at the request of the Project Officer as described in 21 CFR 312.23 (a) (5) using results of preclinical and clinical testing from reports, reprints and other data available from the investigator, developer, or pharmaceutical company
- Participates in multi-disciplinary review of clinical research study documents
- Assists in the review and update of standard operating procedures and work instructions for regulatory processes
- Program goals and objectives are reviewed with the supervisor
- Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research or four (4) years equivalent experience in a related field in lieu of degree
- No experience required with a Bachelor’s degree
- Biomedical research or clinically related experience may be substituted for the degree
- Ability to function independently within a team to build strong relationships with multiple groups
- General knowledge of clinical trial concepts, practices and project implementation
- Ability to communicate effectively, orally and in writing, with both non-technical and technical staff
- Detail-oriented and possesses strong organizational/planning skills and the ability to prioritize multiple tasks/projects
- Knowledge of FDA regulations, 21 CFR, and GCPs
- Must be able to obtain and maintain a Security Clearance
- ECTD preparation and submission experience
- Previous experience or training in life sciences
- Some regulatory management in clinical trials
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Regulatory Associate Resume Examples & Samples
- Providing nutritional calculations for all cereal and snacks projects, advising Food Technologists how recipe changes impact a product’s nutrition profile
- Developing the ‘side panel’ product information for all Kellogg’s products ensuring legal compliance for the European business
- Providing central regulatory sign off for all Kellogg Europe snacks and cereal artworks
- Managing the routine analytical monitoring programme for Kellogg Cereal and Snacks products. Analyzing testing reports with Kellogg Plants to capture trends and agree corrective action plans
- Managing UK & European vitamin premixes maximizing efficiencies & reviewing validation of applications
- Producing finished food specifications for export registrations
- Providing legal and technical support to Consumer Helpline, Customers, Sales and Marketing and local market nutritionists
- Working with Kosher and Halal Food Authorities to gain certification for new products and maintain for existing products
- Previous experience in Regulatory Affairs or food labelling background
- A degree or equivalent in an appropriate food related discipline
- Excellent communication skills across all levels
- You will be computer literate and confident in using all Microsoft applications and any additional software
- You will strive as part of a team but also have the passion and drive to work autonomously
- With excellent numeracy skills you will have attention to detail the role requires
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Regulatory Associate Resume Examples & Samples
- Minimum B.Sc. (advanced university Science degree in Pharmacology or related discipline preferred) plus a post-graduate education in regulatory affairs with more than 3 years regulatory experience in an industry or government setting
- Thorough knowledge of new product and process development, current regulatory issues in Canada, United States, and Europe
- Good technical writing skills and the ability to review and critique safety, efficacy, and quality
39
Junior Regulatory Associate Resume Examples & Samples
- Minimum B.Sc. (advanced university Science degree in Pharmacology or related discipline preferred) plus a post-graduate education in regulatory affairs with 2-3 years regulatory experience in an industry or government setting
- RAC certification preferred
- Knowledge of current regulatory guidelines in Canada,United States, and Europe as related to product development
- Good technical writing skills and the ability to review and critique safety, efficacy,and quality
- ECTD submission experience preferred
- Excellent interpersonal skill and organizational, time management, and communication skills are essential
- Computer literacy in Microsoft Office and Adobe Acrobat
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Senior Regulatory Associate Resume Examples & Samples
- New applications for drugs/biologics
- Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise
- Demonstrated ability to work successfully on project teams
- Manufacturing, QA/QC experience #LI-GZ
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Advertising Regulatory Associate Resume Examples & Samples
- 4+ years of experience in the preparation of complex deliverables under tight deadline constraints; 1+ year of experience in Pharmaceutical , Advertising Agency, or Healthcare industry
- Knowledge of FDA pharmaceutical regulations through appropriate training
- Experience tagging and linking in ZINC
- Working knowledge of Adobe Acrobat
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Senior Regulatory Associate Month Contract Resume Examples & Samples
- Review and approve product formula and labelling
- Responsible for adverse event filing to relevant Health Authorities and maintain internal tracking database
- Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed. Understands stakeholder timelines and objectives
43
Regulatory Associate Resume Examples & Samples
- Preparing/supervising of submission of documents (Initial packages, substantial amendments and other notifications) to the Polish CA
- Filling out initial application forms
- Quality check of submission packages
- Preparing label designs for the investigational medicinal products
- Monitoring changes on the ongoing basis in Poland's and EU legislation
- Advising on Polish regulations, EU guidelines, Polish CA requirements
- Acting in compliance with Poland’s pharmaceutical law, ICH-GCP, EU directives and in line with local and global procedures
- Minimum Work Experience: initial years’ experience in an industry-related environment
- Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
- Language Skills: fluent vocal and written English and Polish
44
International Regulatory Associate Resume Examples & Samples
- Support of regulatory compliance projects for overseas clients
- Collect, produce, maintain and distribute documents pertaining to new and ongoing product registration worldwide
- Provide technical support by obtaining the required documentation from QA and QC and ingredient suppliers as needed for International product registrations
- Generate stats and reports for international sales analytics
- Responsible for monitoring and managing the project schedule including mitigations and risks to project success, and resolving issues as they arise
45
Regulatory Associate Resume Examples & Samples
- Analyze formulation data for variety of food products and enter data into proprietary database
- Ensure that data is accurate and compliant with FDA/USDA regulations
- Generate nutrition sheets for industrial customers
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Regulatory Associate Resume Examples & Samples
- Prepare and submit state feed/pet food/specialty pet food/pet supplements registration packages
- Coordinate with R&D to obtain necessary data needed for regulatory actions requiring data substantiation
- Manage existing state feed/pet food/specialty pet food/pet supplements registrations by managing product renewals and label revisions
- Prepare and submit monthly, quarterly, semi-annual, and annual tonnage reports to applicable government agencies
- Prepare and summit any and all annual facility/company licenses to applicable government agencies
- Develop and maintain regulatory files and electronic databases with respect to new product registrations, product renewals, product discontinuances, facility licenses and tonnage reporting
- Develop and manage SOP’s (Standard Operating Procedures) in order to develop standard work for the feed/pet food/pet specialty registration and regulatory processes
- Stay abreast of applicable state regulations, interpret and communicate impact
- Develop and maintain good working business relationships with relevant government officials as well as internal groups such as Legal, R&D, Marketing, Sales, and Customer Service
- Participate in weekly NPD (New Product Development) meetings to discuss/develop regulatory strategies and state timing for all current and future projects
- Facilitate questions/concerns from governmental officials as they arise with respect to feed/pet food/pet specialty products registered in the states
- Represent organization as requested with industry/regulatory organizations
- Assist in state feed/pet food/pet specialty/pet supplements/tonnage/facility audits
- Assist/Manage the stop sale process and the state sales restriction process (from the department’s view)
- Develop a proficiency in SAP & SPX
- Assist senior staff with projects and tasks
- B.S. or B.A. in chemistry, biology, biochemistry, or similar science
- Exceptions to this education requirement may be made for candidates possessing
- Must be organized and detail-oriented, with solid analytical and decision making skills
- Must demonstrate strong verbal and written communications skills, along with influencing and negotiation skills, process knowledge in functional area, and an ability to communicate regulatory and technical issues in lay terms
- Must demonstrate effective interpersonal and influencing skills and be able to act in an appropriate role depending on the situation – facilitator, contributor, leader, executor, etc
- Must be proficient in Windows-based applications – Word, Excel, PowerPoint, Access (preferred)
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Regulatory Associate Manager Resume Examples & Samples
- Create Nutrition Facts Panels and ingredient lines for all products
- Provide consumer-facing label reviews and guide Creative team on label design
- Approve raw material and finished goods specifications
- Interpret US and international regulations for foods and supplements to ensure regulatory compliance
- Review and approve packaging, advertising, website and communication materials
- Register products, maintain and submit documentation and invoices from state regulatory agencies
- Guide external resources on projects involving international labeling regulations and registrations
- Develop international technical data document process and database for International Logistics and Export teams
- Coordinate efforts for internal and external requests of technical product information
- Partner with State agencies, third parties and internal accounting offices to ensure compliance with state bottle bill requirements
- Substantiate and align product claims for compliance and ensure documentation in place
- Manage internal nutrient database by assuring robust nutrient data from suppliers, USDA and chemical analysis
- Orchestrate nutrition analytical testing, sample submission and documentation management
- Coordinate non-GMO Project compliance internal verification documentation
- Lead documentation control and system testing for regulatory team
- Influence regulatory direction and drive strategy on cross-functional teams at all points in the stage-gate process
- Apply nutrition expertise to identify nutrition opportunities and guide strategic nutrition direction
- Support substantiation of product and nutrition claims and product naming in new areas
- Collaborate with product developers to evaluate supplier data for new or novel ingredients
- Monitor food labeling regulatory activity; assess business opportunities and impact to brands
- Bachelor's Degree in Nutrition or Food Science, or related scientific field
- MSU food law labeling certificate strongly desired
- 5 to 8 years of experience in a Regulatory Compliance (food labeling) role with a CPG food manufacturer; experience in food labeling for nutrition-focused products (cereals, bars, shakes, meals) and/or supplements
- Demonstrated proficiency to interpret U.S. food regulations and strong ability to navigate international labeling regulations
48
Scientific & Regulatory Associate Resume Examples & Samples
- Prepare toxicology/safety or risk assessment reports and data summaries: Conduct information search (or use materials provided), review and interpret data, conduct a critical analysis to assess the credibility and utility of the data for the project, and use initiative to ensure that the selected materials are complete. Synthesize key scientific points, assemble arguments/rationales/calculations regarding safety, and write/revise report
- Review and evaluate toxicological and pharmacokinetic studies on drugs and biologics for regulatory review. Write summaries of a large body of information and/or prepare tables summarizing and positioning data as part of dossiers for regulatory agency review
- Ensure that all required scientific issues are identified in reports and dossiers, which may include forming an opinion and making conclusions based upon the scientific information that has been reviewed
- Assume responsibility for the quality (scientific accuracy, completeness, writing style of the initial draft) of own work both prior to senior scientific review and during revision process. Review own work, peer-review data, or perform Quality Checks as required for project
- Assist senior scientific staff with special requests: e.g., editing of documents, reviewing information, research
- Be responsible for contributing to the overall team effort to keep projects on time, to specifications, and on budget. Coordinate activities with other project team members. Request input from senior scientific staff for high-impact decisions related to projects (or parts of projects). Effectively manage own workload to coordinate multiple projects
- Toxicology or safety risk assessment report at a level acceptable for regulatory agency review
- Written or tabulated summaries of original toxicology data in a format acceptable for regulatory review
- Search of published literature or regulatory/authoritative body databases
- Written toxicology profiles based on original or published information, or both
- Experience in your area of expertise and proven ability in applying toxicological knowledge, including critical evaluation and integration of scientific data from multiple sources, with attention to detail
- Excellent writing skills (English) and effective communication abilities as a professional scientist
- Ability to self-motivate, multitask, and work on a number of different aspects of a project while problem-solving, processing information, and following directions
- Ability to retain clear vision of project goals, plus understand project structure/flow and team dynamics, including need for senior scientific input on projects and guidance to less experienced staff
- Team player and able to prioritize and manage time effectively
- Proficient with computer skills e.g., Word, Excel, PowerPoint, MS Project (if required)
49
Product Regulatory Associate Resume Examples & Samples
- Providing product regulatory consultancy to business units
- Supporting the business unit teams involved in chemicals notifications within control regimes such as REACH
- Supporting new product/process assessments as part of the New Product Introduction Framework
- Developing awareness of global chemical control regimes and product safety regulations
- Supporting chemical hazard classification and communication projects across the range of JM businesses
- Working collaboratively in multidisciplinary project teams, within JM and supporting interactions with trade associations, regulatory agencies and industry consortia
- Strengthening the corporate core competency in regulatory and industrial toxicology
50
Senior Regulatory Associate Resume Examples & Samples
- Overview of the Regulatory activities that enable DuPont Pioneer activities in research, seed production and sales, as well as Intellectual Property enforcement
- Biotech traits registration; new breading technics advocacy work for regulatory determination; regulated material permitting; compliance with regulations; internal audits and trainings; official reports; post-commercial monitoring activities. Corn hybrids and sorghum varieties registration
- Represent the company in Industry Associations, especially in technical discussions aiming to improve the Regulatory environment
- Interface with Government Officials for company matters and/or improvement in regulations
- 5 years of experience in similar positions will be required
51
Regulatory Associate Resume Examples & Samples
- Ability to work as a team and autonomously
- Strong organizational skills and the ability to prioritize
- Continuous Improvement mindset
