A Regulatory Affairs Coordinator acts as a line between the companies and regulatory authorities and ensures that the products manufactured and distributed comply with standard legislation. Key duties listed on the Regulatory Affairs Coordinator Resume are – studying scientific and legal documents; gathering, evaluating, organizing, managing, and collating data in various formats, maintaining familiarity with company product ranges; liaising and negotiating with regulatory authorities; providing advice on regulations to the scientists/manufactures; writing comprehensible, and clear product information labels and leaflets; and preparing necessary documentation.
The nature of the job demands the following skills and qualifications – staying current with the changes in the regulatory legislation and guidelines; IT skills; analytical mind-set; presentation skills, and problem-solving attitude. A good understanding of relevant legal, scientific, and manufacturing areas is also necessary. A relevant master’s degree or a bachelor’s degree with work experience is preferred.
Headline : A hard-working and detail-oriented Regulatory Affairs Coordinator professional with extensive experience in office management, corporate correspondence, records management, scheduling, and data entry. Analytical administrative professional with over 7 years of administrative support experience in a variety of office environments with the ability to balance multiple projects.
Skills : MS Office, Multitasking, Planning.
Description :
Managed department meetings Coordinate travel arrangements for VP of Regulatory Affairs & Quality as well as other members of the team.
Assisted with receptionist coverage as needed to ensure guests are promptly greeted and appointments are kept on schedule.
Maintained department filing system.
Responsible for organizing and assembling monthly correspondence to the FDA.
Proofread and formatted various department documents such as reports, correspondence, as well as presentation slides.
Experience
5-7 Years
Level
Executive
Education
GED
Regulatory Affairs Coordinator Resume
Objective : Extensive knowledge and experience in Regulatory Affairs Coordinator, document management, healthcare safety programs and projects Expert in regulatory and quality assurance processes and compliance, IRBs, INDs, NDAs, ANDAs, government grants and contracts Results-driven project leader in operations, training, public policy and administration.
Reviewed, tracked, and processed the regulatory documentation of the CALGB's membership activities of more than 250 academic institutions and studies, ensured compliance with federal regulations and CALGB's policies and procedures.
Acted as liaison to the National Cancer Institute (NCI), Cancer Trial Support Unit (CTSU), and other cooperative groups for purposes of maintaining the CALGB institutional membership data and protocol study information in the Regulatory Support System (RSS), Clinical Trials Monitoring Branch-Audit Information System (CTMB-AIS) and CALGB proprietary database to resolve discrepancies that related to institutional membership.
Functioned as the primary contact for institutions experiencing problems in patient registration and institutional participation due to incomplete or discrepant regulatory documentation, resolved discrepancies between CTSU/RSS and CALGB databases.
Assisted with the creation, updating, maintenance, and validation of clinical study databases for the provision of computerized reports of the data.
Coordinated collection and review of over 50 adverse event and adverse drug report documentations a day for submission to the NCI, National Institute of Health (NIH), Food and Drug Administration (FDA), CALGB Data Management Center staff, and pharmaceutical companies through the Adverse Event Expedited Reporting System (AdEERS).
Verified over 50 study-specific documentation created and submitted drug distribution checklists for shipment of drugs and provided study accrual updates to over 10 pharmaceutical companies.
Processed over 800 Conflict of Interest (COI) forms annually; collaborated with the COI Committee to review any disclosures.
Experience
2-5 Years
Level
Executive
Education
GED
Regulatory Affairs Coordinator Resume
Objective : As a Regulatory Affairs Coordinator, responsible for Demonstrating independent oversight and management of regulatory affairs activities associated with the review, submission, and approval, renewal, reportable events, and closure of clinical trials submitted through the GHS Office of Research for the following specialties Oncology, Cardiology, and Wound Care.
Skills : Microsoft Office, Supervisory, Communication.
Description :
Used effective time management skills to ensure projects are completed in a timely and accurate manner, researches, supports, and drives to completion the Regulatory Affairs Department's overall objectives and special projects.
Responsible for legal research and interpretation of Federal and State laws and regulations impacting the business.
Supported the Compliance and Legal departments as well as other relevant business units by providing regulatory guidance.
Completed due diligence and State regulatory reporting to ensure company compliance with various laws and regulations.
Responsible for Surety bond upkeep including review of regulatory changes and calculation of bond amounts to ensure appropriate bond levels are maintained.
Reviewed all bond renewals, adjustments, and cancellations.
Prepared documentation for State exams and work to support the Director in order to provide appropriate documentation to State Regulators during examinations.
Experience
2-5 Years
Level
Executive
Education
BS
Regulatory Affairs Coordinator Resume
Headline : Seeking a Regulatory Affairs Coordinator position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.
Collaborated with Quality Assurance to meet requirements for the FDA and the MHRA ensuring all training and accreditations were met within a highly regulated atmosphere.
Reviewed examination reports with management and submits company response to State Regulators.
Completed licensing research and submits license applications for all Sigue Corp.
Developed and implemented standard operating procedures for all regulatory activities.
Identified and communicated changes in regulatory policies, as well as their potential impact relative to internal and external stakeholders initiating recommendations and corrective action, plans to reduce the risk of non-compliance.
Generated cover letters, table of contents, divider tabs, and other administrative components necessary for outgoing correspondences.
Advised clinical team on all regulatory needs during monitoring visits and through the lifecycle of the study.
Experience
5-7 Years
Level
Executive
Education
BA
Regulatory Affairs Coordinator Resume
Headline : Seeking a Regulatory Affairs Coordinator position, responsible for Performing detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance. Coordinates submissions with offsite publishers.
Skills : Problem Solving, Customer Service, Leadership, Microsoft.
Description :
Provided manage problem-Solving, Customer Service, Leadership, Microsoft. ent of the overall structure and regulatory requirements for all research protocols.
Coordinated and oversaw Initial IRB submissions.
Reviewed ICFs; worked with internal/external customers to write a final copy.
Worked alongside the clinical trials manager and contracts analyst to assure final ICF is in line with contract and budget.
Prepared, submitted, and maintained regulatory documents needed for all IRB submissions (local or central IRB).
Managed submissions of annual continuing reviews.
Prepared all studies in the IntelliTrial Clinical Trial Management Program.
Experience
5-7 Years
Level
Executive
Education
MS
Regulatory Affairs Coordinator Resume
Objective : Regulatory Affairs Coordinator with 2+ years of experience in Participating in internal team meetings, represents US/LA Submission Operations on teams as necessary, reviews and authors documents, meets timelines.
Skills : Microsoft Office, Liquent Insight, EPIC File Management.
Description :
Coordinated, wrote, and submitted Supplements, Amendments, Annual Reports, and ADEs to the FDA for ANDAs.
Assisted in the preparation of ANDAs.
Provided project team representation between Regulatory Affairs and other departments.
Developed, edited, and reviewed labeling and advertising, and promotional material for compliance with regulations.
Reviewed and approved batch records, product specifications, test methods, and labeling.
Facilitated and compiled inspection documentation and generate FDA inspection minutes.
Conducted internal GMP documentation audits.
Experience
2-5 Years
Level
Junior
Education
BS
Regulatory Affairs Coordinator Resume
Objective : Hardworking, organized, Regulatory Affairs Coordinator professional with a proven background delivering sensible business technology solutions on time and under budget while working as a team member or team leader.
Led and directed Student Services departments at each campus through effective teamwork and communication.
Processed and managed project flow of education, regulatory and compliance submissions, and reports.
Maintained project calendars, timelines, and matrixes.
Maintained all policies and procedures including, but not limited to: onboarding schedules, course catalogs, student policy handbooks, faculty handbook, enrollment agreements, and applications.
Prepared and released student satisfaction survey executive summaries.
Developed intranet sites and marketing for the Student Services department, online store, and Education departments.
Optimized the quality of all data moving into and out of inventory information systems.
Experience
2-5 Years
Level
Executive
Education
Diploma
Regulatory Affairs Coordinator Resume
Objective : To apply for the Regulatory Affairs Coordinator position in your organization and fulfill the essential functions necessary by utilizing the experience and knowledge obtained within Regulatory Operations.
Skills : Proficient In Microsoft Word, Records Management, Phone, Computer, Clerical.
Description :
Tracked international product complaints, coordinated complaint sample returns, act as a liaison between complainant and manufacturing division, prepare evaluation letters summarizing complaint investigations.
Acted as the International Regulatory Release Coordinator.
Confirmed international registration status and release product to a requested country in JDE.
Acted as the Engineering Change Notice Coordinator.
Logged Engineering Change Notices on tracking spreadsheets, requested Change Notice Impact Assessments from international representatives, summarized impact assessment results for manufacturing division.
Created and maintained a Product Catalog spreadsheet.
Created and maintained an International Registration spreadsheet with product codes.
Experience
2-5 Years
Level
Executive
Education
Diploma
Regulatory Affairs Coordinator Resume
Headline : Seeking a Regulatory Affairs Coordinator position in an administrative / office environment where my experience and skills will benefit the efficiency and operation of your company.
Skills : Microsoft Office Suite, Data Management, Electronic Medical Records, Customer Service, Electronic Health Records, Communication.
Description :
Managed development, preparation, and distribution of research related communications between physicians, nurses, research coordinators, government and commercial sponsors, as well as review committees.
Maintained regulatory files and tracking system for all studies under the direction of the Clinical Research Unit and ensured compliance with federal regulations and institutional policies.
Prepared and submitted investigator-initiated Investigational New Drug Applications to the Food and Drug Administration (FDA).
Supervised the integration of new research-related information with project documents.
Coordinated team to develop and implement an advanced computerized research-specific database for the Cancer Center.
Oversaw daily maintenance of the database.
Prepared data and reports for presentations and for preparation of Core Grant, Eastern Cooperative Oncology Group (ECOG) grant, and other similar grants.
Experience
5-7 Years
Level
Executive
Education
BS
Regulatory Affairs Coordinator Resume
Objective : Regulatory Affairs Coordinator with 5+ years of experience in Assisting faculty in writing Investigational New Drug applications and annual reports for investigator-initiated clinical trials. Coordinate initial and ongoing submissions, and annual reports to the Food and Drug Administration.
Skills : Advanced In MS Office, Detail Oriented, Team Player, Ability To Multitask, Works Well With Others.
Description :
Provided administrative support to Executive VP of Regulatory Affairs.
Prepared the annual state distributor and wholesale licenses.
Handled returned goods and product complaints.
Tracked document change control notices.
Assisted in quality assurance compliance to include complaint investigations and reports.
Prepared travel arrangements, schedules, and coordinated meetings.
Prepared and submitted department expense reports.
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