Regulatory Affairs Coordinator Resume Samples

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G Howe

Glen

Howe

91617 Donnelly Street

Philadelphia

+1 (555) 955 6885

91617 Donnelly Street

Philadelphia

Phone

p +1 (555) 955 6885

Experience Experience

Dallas, TX

Regulatory Affairs Coordinator

Dallas, TX

Goyette and Sons

Dallas, TX

Regulatory Affairs Coordinator

Tracking and facilitating the progress of new trials through the review process
Writing plain language informed consent documents
Working knowledge of clinical trial strategy and study design, statistical methods and data reporting
Offer assistance to support staff when new programs are instituted by the Company
May communicate with regulatory agencies or other consultants to coordinate the distribution and implementation of any new forms, SOPs, or current industry information to internal/external customers
Coordinates the on-boarding and documentation of new research staff within the USO network. Assists Transitions and Disaffiliation internal team to deactivate profiles, mail and file documents. 40%
Maintains close working relationship with R&D, Medical, Supply, Legal and Marketing staff to support team structure and is responsibility for influencing growth and development of the brands within the therapeutic area

San Francisco, CA

UK Regulatory Affairs Coordinator

San Francisco, CA

Lind, Mann and Walker

San Francisco, CA

UK Regulatory Affairs Coordinator

Brief CS interviewees ahead of regulatory meetings. Provide overviews of regulatory themes and issues and prepare staff for regulatory dealings
Tri-angulate with regulatory counterparts in US, APAC & EMEA/Switzerland to share knowledge and global regulatory strategies
Run the ongoing BAU relationship with PRA and FCA, responsible for administration, providing pre-data and reports, hosting meetings, distributing and tracking to completion any follow on actions
Prepare regulatory overview documentation for governance bodies and audit committees
Act as primary contact point between the Firm and the PRA / FCA and support coverage of relationships with regulators in other key EMEA locations
Uphold standards expected by CS in all regulatory dealings. Ensure that all regulatory meetings are accurately captured, and correctly administered
Manage Continuous Assessment supervisory process. Assemble and lead internal project board to gather potential issues, construct briefing manual, conduct briefings to staff (mass & individual), host all regulatory interviews, distribute themes and issues throughout regulatory visit, distribute findings, identify themes and ensure that regulatory sentiment is fully understood

present

Boston, MA

Dach Regulatory Affairs Coordinator

Boston, MA

Franecki-Wolf

present

Boston, MA

Dach Regulatory Affairs Coordinator

present

Create working instructions for IT business support applications and train them accordingly (COUPA, PEGA, SAP, etc.)
Order management of office and IT related equipment
Structure and control of new meaningful regulatory IT infrastructure and Share Point folder lists to allow efficient team integration work
Provide translations for review of AdProm Material
Support travel planning and expense management for DACH RA team and Head of EU LOC RA
Provide product related regulatory translations (German – English or vice versa) including agency communication, decisions
Proof reading of translated SmPC and PIL and related product labelling (artwork) according to regulatory standards (QRD template)

Education Education

Bachelor’s Degree in Science Required

California State University, Northridge

Bachelor’s Degree in Science Required

Skills Skills

Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review
Strong knowledge and understanding of Microsoft Office
Ability to Research and analyze applicable regulations
Demonstrated skills in areas of communication, performance management, research and interpretation of regulations, and managing complex projects through matrix relationships
Good organizational skills, time management and follow up skills able to prioritize and handle several tasks simultaneously
Good command of the English language, in both written and verbal form. Proficient in Windows, as well as MS Word, Excel, PowerPoint
Excellent organizational skills and attention to detail
Knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials
Ability to work in fast paced environment and handle multiple tasks
Proficient in MS Office Word, Outlook and Excel

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UK Regulatory Affairs Coordinator Resume Examples & Samples

Act as primary contact point between the Firm and the PRA / FCA and support coverage of relationships with regulators in other key EMEA locations
Manage Continuous Assessment supervisory process. Assemble and lead internal project board to gather potential issues, construct briefing manual, conduct briefings to staff (mass & individual), host all regulatory interviews, distribute themes and issues throughout regulatory visit, distribute findings, identify themes and ensure that regulatory sentiment is fully understood
Run the regulatory deliverables tracker, responsible for ensuring that the various regulatory initiatives are known and understood by the various stakeholders within CS. Project managing these initiatives, tracking to completion and timely escalation of potential issues
Run the ongoing BAU relationship with PRA and FCA, responsible for administration, providing pre-data and reports, hosting meetings, distributing and tracking to completion any follow on actions
Ensure that all regulatory requests are fully understood by the relevant stakeholders, organise regulatory requests into tangible deliverables, track to completion and timely escalation of potential issues
Co-ordinate the Firm’s response to formal regulatory “Dear CEO” letters. Organise regulatory requests into tangible deliverables, track to completion and timely escalation of potential issues
Uphold standards expected by CS in all regulatory dealings. Ensure that all regulatory meetings are accurately captured, and correctly administered
Brief CS interviewees ahead of regulatory meetings. Provide overviews of regulatory themes and issues and prepare staff for regulatory dealings
Tri-angulate with regulatory counterparts in US, APAC & EMEA/Switzerland to share knowledge and global regulatory strategies
Prepare regulatory overview documentation for governance bodies and audit committees
Co-ordinate regulatory reporting suite. Collaborate with stakeholders to ensure that accurate and appropriate information is provided in response to regulatory requests for information
Investment banking experience in control/risk functions
Experience of presenting to senior management
Experience having worked in a high pressure environment
Solid analysis skills and is intellectually inquisitive
Manage to learn and prepared to review detail
Operational Risk / Internal Audit / Regulatory background and/or experience
Confidence and ability to be self-starter
Understanding of sales and trading floor dynamics
Solid work ethic
Interest in learning Controls Framework
Knowledge of UK regulatory environment
Solid Microsoft (Excel/PowerPoint) skills
SharePoint experience preferable
MICOS experience preferable
Firm infrastructure experience helpful

Regulatory Affairs Coordinator Resume Examples & Samples

A Bachelor’s degree or related discipline or previous work experience in Regulatory Affairs that is equal to a 4-year degree is required
A minimum of 2-3 years of previous work experience in banking, lending, audit or compliance-related environment is required. Prior regulatory or government work experience and knowledge of banking and lending is preferred
Must be able to demonstrate proficiency with the following skills

Regulatory Affairs Coordinator Resume Examples & Samples

Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review
Coordinates the planning, preparation, data collection, assembly, review and publication of regulatory submissions to the FDA and other government agencies
Reports and responds to agencies inquiries or comments
Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies
Prepares regulatory reports and coordinate data collection and reporting with other departments
Tracks changes in regulatory guidelines as they may occur
Prepares updates on laws, regulations and guidelines for distribution to appropriate study personnel and investigators
Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses
Supports PI.s and study staff by assisting in the data collection and notification required for reporting of Adverse Events
Facilitates communication with IRB related to Adverse Events
Supports study monitoring, as needed and requested
Assists with regulatory affairs training
Time management and organizational skills
Knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials
Working knowledge of clinical trial strategy and study design, statistical methods and data reporting
Familiarity with medical and/or scientific terminology Proficient in use of MS Office software packages, spreadsheet analysis, database analysis

Regulatory Affairs Coordinator Resume Examples & Samples

Bachelor’s Degree in any field from an accredited college or university
One (1) year of clinical and/or research experience
One (1) or more years of regulatory experience
Experience working with NCI, Industry and Investigator initiated clinical trials
Experience working in an academic and/or medical environment
Experience working with University of Colorado Systems
Basic understanding of research specific to Human Subject Research protection, Good Clinical Practice, and IRB requirements
Good command of the English language, in both written and verbal form
Proficient in Windows, as well as MS Word, Excel, PowerPoint

Cpdm Regulatory Affairs Coordinator Resume Examples & Samples

Bachelor’s degree focused in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration, or other related field of study
Two (2) years of clinical and/or regulatory research experience
Two (2) or more years of oncology research and/or academic regulatory experience
Experience with submissions to IRBs, and/or the FDA for IND or IDE
Experience working with Investigator Initiated clinical trials
Experience handling and prioritizing detailed tasks and meeting deadlines
Ability to problem solve and multi-task
Understanding of research standards as set forth by FDA, OHRP, UCH, UCD and NCI
Proficient in Windows, MS Word, Excel, PowerPoint
General understanding of Anatomy and Physiology and Medical terminology a plus

Regulatory Affairs Coordinator Resume Examples & Samples

Bachelor's degree in science required
One to three years of direct, industry-related Regulatory experience in relevant industries
Solid experience with Regulatory submissions (Rx and/or OTC) to FDA. Experience with interfacing with Regulatory agencies highly desirable. Experience with international Regulatory submissions and compliance a plus
Knowledgeable in current policies, practices, trends, technology, and information affecting the over the counter industry. Knows how the OTC environment works and has an awareness of competitors and their products
Introductory working knowledge of good manufacturing practices (GMPs), US pharmaceutical regulations, good clinical practices (GCPs) and good laboratory practices (GLPs)
Excellent team interaction skills along with demonstrated ability to work on a cross-functional team
Skilled in leveraging Microsoft Office programs and other relevant software
Participate in day-to-day operations of the OTC team, including ensuring all product and project-related milestones are met. Responsible for 2nd level label reviewer activities, maintain project plan oversight
Implement Regulatory strategies to ensure successful promotion and compliance, for marketed Healthcare products
Maintain close working relationship with the Global Regulatory Team to ensure alignment of local (US) Regulatory strategies with Global/Regional strategies
Provides Regulatory support and expertise to project teams, through Regulatory strategies and consultation on deliverables that could potentially impact the project/product
Ensure compliance with all internal and external regulatory requirements
Contribute to the evaluation and analysis of the impact of trends relative to government regulatory agencies
Participate in the preparation of major regulatory filings, and ensures timely completion of routine regulatory submissions required for maintenance of in-market products. Reviews technical reports prepared in support of regulatory filings
Maintains close working relationship with R&D, Medical, Supply, Legal and Marketing staff to support team structure and is responsibility for influencing growth and development of the brands within the therapeutic area

Product Stewardship & Regulatory Affairs Coordinator Resume Examples & Samples

Knowledge of chemistry is preferred
Organized and a strong attention to detail
Basic awareness / knowledge on Product Safety and Regulatory Affairs is preferred
Require strong communication, coordination, and documentation skills in a global and regional team environment
Good English on both written and spoken

Regulatory Affairs Coordinator Resume Examples & Samples

Administrative background, medical/scientific background is an asset
1-3 years administrative or customer service experience preferred (Entry level accepted)
Good organization skills, effective time management, Autonomous
Active listener
Conscientious, Detail oriented
External Interactions with external manufacturers
Internal Interactions with Manufacturers Regulatory Affairs counterpart (BWIUS products and BWIIL products), EDC, Johnson & Johnson local regulatory affiliates in EMEA, marketing department, quality department, technical department, clinical department and finance department, Supply Chain / GMED
Fluent written and oral English communication skills
Good Computer skills: Outlook, Excel, Power Point

Regulatory Affairs Coordinator Resume Examples & Samples

Associates degree or greater
Experience with MS Office products and database applications
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

Regulatory Affairs Coordinator Resume Examples & Samples

High school graduate or equivalent with a minimum 9 years of progressively increasing administrative experience, at least 5 years of which must have been in a clinical research, regulatory, or technical environment
Hands-on regulatory administrative/clerical experience including use of regulatory related databases is required
A thorough knowledge and understanding of regulatory submission requirements, CTD format, TRDs and other related material is essential
An understanding of the information required for foreign regulatory submissions is desirable
Must have an understanding of and experience in utilizing medical and technical terminology in a regulatory environment
Must be fully cognizant of and responsive to shifting priorities and be able to interact with professional staff at all levels
Excellent organizational and verbal/written communication skills are necessary
Independent judgment, discretion and problem solving is required
Excellent computer skills and professional demeanor required for interactions with international colleagues and health authority representatives, including a working knowledge of database management as well as proficiency in Microsoft Word, Excel and PowerPoint

Regulatory Affairs Coordinator Resume Examples & Samples

Bachelor's degree in an applicable field
No experience required
Familiarity with medical and/or scientific terminology
Proficient in use of MS Office software packages, spreadsheet analysis, database analysis

Research Regulatory Affairs Coordinator Resume Examples & Samples

Prepares and submits research applications and performs regulatory study start up activities, drafts and or edits informed consents and other related documents, assists Principal Investigators (PIs) with protocol and document development, provides ongoing continuation reports to the Institutional Review Board (IRB) which include adverse event reporting, study amendment reporting, and coordination of submission to respective IRB. Conversely, a coordinator working with the Institutional Review Board will review, recommend changes or corrections, and prepare study related submissions for review by the IRB
Develops and maintains all regulatory documents including study amendments, recruiting material, continual reviews and safety reports per guidelines and regulations of the sponsor and the participating institution per IRB, FDA and other applicable Federal, State and local regulatory agencies
Serves as the regulatory representative and professional resource for any site-specific projects or those submitted to the IRB. Interacts on behalf of the physician investigators or the IRB with sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments
Responsible for the development and maintenance of the investigative sites study and regulatory documents and assures compliance with FDAs Good Clinical Practice guidelines. If employed as coordinator for the IRB, assures timely completion and filing of necessary Federal Wide Assurance (FWA) documentation with the Office for Human Research Protection (OHRP) and the annual report required by the Office of Research Integrity (ORI)
Functions as the established site point- person who provides information to the PI, Research director and study staff of submissions and approvals of study related documents. Maintains protocol status updates for pending and active projects. Functions as the site point-person for sponsors and Contract Research Organizations (CROs) to provide requested documents throughout the study existence and at monitoring and auditing visits conducted at the sites. Will be available to participate in site initiation visits for review of site regulatory binders. May be designated as the point-person for audits by regulatory agencies (i.e. OHRP, ORI, and FDA)
Coordinates daily operational activities consistent with the needs of clinical research staff or the Institutional Review Board to ensure timely submission of all regulatory documents and requests of sponsors. Engages in core measures of customer service and provides a professional example of the conduct of medical research to ensure human subject protection
May be required to conduct other administrative duties to support Research Directors or the Institutional Review Board Chair

Regulatory Affairs Coordinator Resume Examples & Samples

Submits, tracks and processes protocol amendments for National Clinical Trials Network (NCTN) studies within the required 90 day period
Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Cancer Center. This may include, but is not limited to, the following
Colorado Multiple Institutional Review Board (COMIRB)
Western Institutional Review Board (WIRB)
NCI Central Institutional Review Board (CIRB)
Protocol Review and Monitoring System (PRMS)
Hospital Research Support Services (UCH-RSS)
University of Colorado Hospital Clinical Trials Office (CTO)
Completes and submits continuing reviews, amendments, and other protocol-
Navigates applicable NCTN websites. This may include Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG) and NRG Oncology (NSABP, RTOG, GOG)
Updates OnCore with regulatory documents and dates
Good command of the English language, in both written and verbal form. Proficient in Windows, as well as MS Word, Excel, PowerPoint

Regulatory Affairs Coordinator Resume Examples & Samples

Supervise workflow processes for the submission of regulatory documents
Ensure timely submission of these documents by bringing to management’s attention any problems, discrepancies and by offering any alternative solutions or more efficient workflow processes
Coordinate with Regulatory Submissions and Documentation on the preparation of regulatory submissions using current electronic publishing programs
Help to establish and communicate priorities of regulatory submissions to customers
May communicate with regulatory agencies or other consultants to coordinate the distribution and implementation of any new forms, SOPs, or current industry information to internal/external customers
Supervise and/or train other specialists in use of forms or new formatting requirements
Verify integrity of documents
Supervise the processing of document entry into the client’s document systems in a timely and efficient manner to guarantee confidentiality and accuracy for use in future submissions, in the event of an inspection by regulatory authorities, or during internal audits
Support and maintain any tracking databases using appropriate software packages as directed by regulatory management, or as required
Verify compliance with current SOPs and company policies
Distribute database systems for tracking of information to appropriate customers
Work with cross-functional management to gather and provide information on priority projects
Verify and coordinate quality control of submissions as well as proper compliance with department SOPs and Regulatory Authority guidelines
Provide appropriate training and encourage productivity and variety in assignments
Ensure adherence to SOPs, policies and procedures
Offer assistance to support staff when new programs are instituted by the Company

Regulatory Affairs Coordinator Resume Examples & Samples

Represents the company in all inspections, forum or meetings which has in anyway related to Product Regulatory affairs as may be deemed required by the company
Provides timely updates on new and latest memorandum from the office of Food and Drug Administration (FDA) for the Philippines affiliate
Assist in the verification of any inquiries related to Product Registrations of All Estee Lauder Brands marketed and to be marketed in the Philippines
Proactively monitor and track the availability of the Formulation to facilitate smooth and timely notification
Timely application / renewal of product notification with FDA
Responsible to properly maintain and update Product Information file (PIF) in accordance to Asean Cosmetics Directives and FDA Requirements
Responsible to properly maintain and update the Global Product Regulatory ST (PRST) on a timely manner
Collaborates with the Marketing team regarding the Advertising requirements related to New Product Launches and promotions
Assist the Sr. Supply Chain in raising the quarterly billing to TRD on regulatory services
Pro-actively participate in ad-hoc projects & streamline processes as identified during course of work
Participate in resolution of any constraints and issues related to product registration
College graduate and completed the Board of Pharmacy
Minimum of 1 year experience and active holder of Professional Regulatory Commission as Pharmacist or related profession
Attendance on Asean Cosmetics Directive and GMP Modules is preferable
He / She should be computer literate. Preferably with proficiency in Microsoft Excel
Willingness and openness to change processes
Customer Service Orientation
Flexible, positive, open-minded, very structured and precise
Good communication skills, written and verbal
Good organizational skills, time management and follow up skills able to prioritize and handle several tasks simultaneously

Regulatory Affairs Coordinator Resume Examples & Samples

Coordinate clinical trial initiation procedures including regulatory document submissions
Assure adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies
Assure staff and investigator training on and adherence to Department of Radiology clinical trials SOPs; maintain and update these SOPs
Assist with preparation and negotiation of study budgets, submission of confidentiality and clinical trials agreements to the Office of Grants and Contracts, and site initiation visits
Assist with recruitment and interview prospective subjects for clinical studies and educate potential subjects about the details of the study through phone contacts, personal interviews, and informed consent
Schedule subject visits and coordinate all personnel required for the visits when required
Collaborate with clinical staff in the hospital to ensure tests and procedures are scheduled and performed correctly; provide an initial orientation to new study protocols
Assure compliance with protocol requirements and complete necessary records. Accurately transfer source documentation into electronic Case Report Forms (CRF). Maintain all clinical research patient files
Recognize adverse and serious adverse events, and provide prompt notification to the appropriate parties
Prepare documentation for sponsor monitoring visits and FDA audits
Enhance research growth within the Radiology faculty by providing focused education programs including topics such as the IRB submission process and the availability of research resources
Educate new investigators and staff about clinical research regulatory and data collection requirements
Identify appropriate clinical trials for Radiology participation and facilitate faculty involvement
Assist with coordination of the tumor measurement and protocol review services and ensure adequate coverage during vacations and other absences
A Bachelor’s degree and a minimum of 1 year regulatory experience
Experience with industry sponsored clinical trials
Knowledge of Good Clinical Practice guidelines and FDA regulations
Experience with sponsor and/or FDA audits of clinical trials
Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task
Demonstrated knowledge of basic human anatomy, physiology, medical terminology, and computers
HIPAA and human subjects’ certifications
Experience with NIH sponsored clinical trials
Knowledge of study budgeting and billing processes
Experience working in the EPIC electronic medical record system
Experience working in the OnCore research management system

Regulatory Affairs Coordinator Resume Examples & Samples

Assist with audit preparations
Coordinate, obtain, legalize, compile and distribute documents needed to support global regulatory submissions. Organize and maintain submission and technical paper files
Generate and maintain database of product reference numbers vs. FDA submission, technical files, CE Mark, etc
Handle/manage process for license registrations. Research regulation requirements upon renewal
Maintain and renew FDA establishment registrations and product listings at Federal level
Prepare, request and track government certifications to ensure smooth transition with registration of new products in global market. Administer certification request system
Provide metrics and reports to support RA/QA needs, Management Review, Monthly reports, etc. Submit requisitions and process check requests with Accounts Payable
Review and update TIs and SOPs as related to product registrations, licensing, certificates and state registrations
Review state rules and regulations on annual basis and submit new and/or renew, revise pharmacy wholesale licenses throughout the U.S as applicable
Update and renew product listing and facility registrations with FDA and Health Canada

Regulatory Affairs Coordinator Resume Examples & Samples

Bachelor’s degree or higher in a Science discipline from an accredited institution
Minimum of two (2) years regulatory experience with drug and/or medical device products
Bachelor's degree or higher in Biology, Chemistry or related disciplined from an accredited institution
Previous experience with structured product labeling, electronic publishing, and electronic submissions
Detailed oriented, ability to navigate a matrix environment
Experience working on a cross-functional team

Regulatory Affairs Coordinator Resume Examples & Samples

Under general supervision, performs functions that require full knowledge of general aspects of the job
Assists with marketing materials review and submission process through CMS Health Plan Management System (HPMS) or CEC Portal
Maintains calendar management for HPMS submissions
Responsible for entering questions and answers in SharePoint which were researched by Regulatory Affairs
Responsible for creating and maintaining a library of CMS communications for ESCO business
Participates in Department’s initiatives to support the implementation of corporate quality goals and action plans
Provides day to day support to the FHP Regulatory Affairs Department ensuring timeliness, accuracy and efficiency in the completion of all pertinent regulatory functions and related projects
Supports the FHP Regulatory Affairs Department’s collaboration with the FMCNA Compliance and Corporate Law Departments to facilitate the development and implementation of programs, policies and procedures based on best practices and regulatory requirements
Escalates issues to supervisor for resolution, as deemed necessary
1 – 2 years’ related experience
Preferred legal or regulatory experience in a Medicare Advantage program
Demonstrated skills in areas of communication, performance management, research and interpretation of regulations, and managing complex projects through matrix relationships
Strong personal computer skills

Commercial Compliance & Regulatory Affairs Coordinator Resume Examples & Samples

Bachelor’s degree in business administration, economics, healthcare administration, or other related field
4 years of demonstrated successful experience working with administrative, policy and/or operational aspects of commercial health plans
3 years of demonstrated success in progressive leadership roles and/or management experience
Consideration may be given for candidates who have an advanced degree in a related field, or comparable experience in lieu of a bachelor’s degree in the stated field
Consideration may be given for candidates who have comparable experience with administrative law and/or regulated industries

Regulatory Affairs Coordinator Resume Examples & Samples

Completion and submission of new clinical trials applications to the IRB
Writing plain language informed consent documents
Tracking and facilitating the progress of new trials through the review process
Correspondence with the IRB, investigators and sponsors throughout the review process
Collection, completion, and submission of regulatory documents to various regulatory entities
Creation and maintenance of regulatory binders and other relevant files during the review, approval, and activation process for new trials
Prior regulatory or clinical research experience with an academic medical center or industry preferred
Detail-orientation with the ability to manage multiple projects simultaneously
Candidates with no relevant experience will be hired as CRC I

Regulatory Affairs Coordinator, Compliance Resume Examples & Samples

Assists with the development and maintenance of master filing systems (submissions, compliance, government relations)
Proactively manages administrative aspects for the department
Labeling and Promotional Review
Work with cross-functional departments to coordinate label review materials
Prepare label review meeting agendas
Maintain labeling and promotional review databases
Coordinates review and release of final promotional materials for biotherapeutic portfolio
Prepares FDA 2253 submissions and submits to FDA with Supervisor approval
Assists with pharmacovigilance processing and tracking of all PV related costs
Provides support for audits by compiling requested documents, keeping records up to date and accurate (audit ready)
Assists with SOP processing and updates in Master Control
Verifies that RA department office supplies are maintained at adequate levels

Regulatory Affairs Coordinator Resume Examples & Samples

Coordinates the on-boarding and documentation of new research staff within the USO network. Assists Transitions and Disaffiliation internal team to deactivate profiles, mail and file documents. 40%
Coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications and tracks collection progress through CTMS and other task tracking systems. 30%
Prepares mail-outs to send to sponsors and quality checks documentation in document management systems to ensure files are complete. 15%
Schedules and attends internal and external business meetings to capture accurate meeting minutes and action items. 10%
Other duties as assigned. 5%

Regulatory Affairs Coordinator Resume Examples & Samples

Some knowledge of regulatory affairs requirements for distributors at the state and federal levels (i.e., BOP and FDA) would be beneficial; not rquired
Good decision making capabilities
Detail oriented and organized
Ability to Research and analyze applicable regulations
Proficient in MS Office Word, Outlook and Excel
Previous experience in healthcare, pharmaceuticals or clinical desired but not require

Dach Regulatory Affairs Coordinator Resume Examples & Samples

20 % of time: Business Administration
Organization of travel, internal and external meetings including invoicing and budget control in adherence with company travel policy
Writing and distribution of meeting minutes
Prepare slide presentations, revise drafts for agency meetings
Organize incoming and outgoing mail
Structure and control of new meaningful regulatory IT infrastructure and Share Point folder lists to allow efficient team integration work
Overall budget control including regulatory fee oversight and fee retention calculation to Finance
Order management of office and IT related equipment
Create working instructions for IT business support applications and train them accordingly (COUPA, PEGA, SAP, etc.)
Respond to global or regional EU RA / Business enquiries by consolidating a harmonized DACH country response (table overviews) by outlook based on an individual action item (AI)
Support RA Lead DACH in any delegated AI relevant RA or business task
AOB
20% of time: Administrative Regulatory Affairs support for EU LOC team
Support consolidation tasks at European LOC RA level on topics of common regional interest, under guidance of EU LOC RA Head
Ensure monthly key submission status / team highlight report input collection and final formatting and distribution
Support travel planning and expense management for DACH RA team and Head of EU LOC RA
40 % of time: Technical RA support
Provide product related regulatory translations (German – English or vice versa) including agency communication, decisions
Proof reading of translated SmPC and PIL and related product labelling (artwork) according to regulatory standards (QRD template)
Responsible for updating all local health authority or non-health authority associations with most current prescribing information / SmPC versions etc. including update of compendia services (e.g. Fachinfo-Service, Rote oder Gelbe Liste in DE etc.),
Issue or update brief product PI labeling text for promotional material (“Pflichttext”) according to Heilmittelwerbegesetz (HWG) in close collaboration with Information Officer
Liaise with marketing and commercial to ensure that all local product information used are up to date
Update RA web page
Update product e-catalogue with most recent PI / SmPC information
Update company web page with RA specific information in close collaboration with Communications
Review and update the regulatory SOP system and related (external) training documentation
Provide IT related support for specific IT applications essentially needed to do RA business including brief trainings, generate working instruction sheet updates (e.g. Webex functionality, VCs, Promomats, VEEVA Registration tracking, e-product catalogue, PEGA, SAP, COUPA etc.)
20 % of time: Product Labeling & AdProm Material review
Provide translations for review of AdProm Material
Review promotional material for compliance with standard of terms and local regulations in close cooperation with the Information Officer and / or product specialist
Support clinical trial applications or agency database update with study reports in close cooperation with product specialist
Number of years of experience: 3-5 years
Field of expertise: Office Management, regulatory affairs or equivalent experience within a pharmaceutical company, CRO, or similar organization
Loyal
Organised and structured
Keeping deadlines and commitments
Self-motivation
Very good written and verbal (English) communication skills
Knowledge of regulations
Oriented towards technical details
Proofreading and editing skills
Manage multiple tasks and deadlines
Resilient
Comply with company regulations / standards and protect Shire´s public reputation
German Excellent
English Excellent
French (would be an asset)

Regulatory Affairs Coordinator Resume Examples & Samples

Assist in preparation and submission of pre-study regulatory documentation to pharmaceutical
Assist in submission for UPMC General Clinical Research Committee and Magee-Womens Hospital Clinical Research Center
Assist in submitting new IND applications to the FDA
Communicate approval to appropriate individuals at cooperative group headquarters
Computer aptitude necessary to operate word processing, spreadsheets, etc. applications
Demonstrated regulatory skills, including knowledge of local and federal IRB submission processes
Facilitate processing and approval for cooperative group trails (GOG) new protocols and amendments
Interpersonal and communication skills necessary to establish and maintain effective relationships with staff, investigators and Institutional Review Boards
Knowledge of regulatory guidelines
Notify investigators and coordinators once approval has been obtained
Oversee processing of all protocol amendments in a timely matter
Prepare modifications for the IRB, revise protocol summaries and consent forms and complete the necessary steps for resubmission to the Board
Prepare protocols for submission to Institutional Review Boards, (University of Pittsburgh Medical Center, University of Pittsburgh Cancer Institute and Magee-Womens Hospital)
Process annual renewals with all of the Institutional Review Boards
Review and distribute the IRB's feedback to investigators
Submit adverse event reports and safety reports to the IRB
Submit termination notices and final progress reports to the IRB
Track the status of all protocols, from initial IRB submissions until final approval
Level of knowledge equivalent to that ordinarily acquired through completion of a BSN or Bachelors Degree in related field
Two years experience in Research and Regulatory Affairs division
Previous experience with IRB submissions for grant-funded studies is strongly preferred

Federal Regulatory Affairs Coordinator Resume Examples & Samples

Bachelor's degree, preferably in science, healthcare, or other related field. Significant experience in research coordination or regulatory work may be substituted for educational requirements
Minimum of two years of experience in healthcare, research or clinical setting with regulatory compliance familiarity
Working knowledge of computers, standard office software packages (Word, Excel, Access, Power Point, etc.), standard office equipment (photocopiers, facsimiles, telephones, pagers, etc.)

Regulatory Affairs Coordinator Resume Examples & Samples

Organize and maintain files/databases
Gather information and data from other departments and external resources for regulatory submissions
Assemble regulatory documentation for regulatory submissions
Register all Arthrex facilities and devices with the FDA
Order documents, subscriptions, articles, standards and other items
Coordinate office functions; maintain office supplies & equipment, copying, scanning, typing correspondence and meeting notes
Effective Project Coordination skills
Strong knowledge and understanding of Microsoft Office
Ability to work in fast paced environment and handle multiple tasks