regulatory affairs associate resume example with 4+ years of experience
JessicaClaire
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Professional Summary
A Regulatory and Clinical Pharmaceutical Industry Professional with extensive experience of document publishing, submission compilation, life cycle management and dispatching global regulatory submissions compliant with Health Authority electronic requirements. Looking for opportunities in the area of regulatory affairs, in the Pharmaceuticals, Bio-pharmaceuticals and Medical Devices industry.
Skills
• Excellent working knowledge and advanced experience with FDA/ICH guidances for INDs, sNDS, NDAs, ANDAs, BLAs and major supplements/amendments.
• Collaborative knowledge of eCTD publishing, IND, NDA, IND-NDA annual reports, NDA/ BLA cover sheet, eCTD filing and authoring submissions.
• Experience in Regulatory Publishing using eCTDXPress, FirstDoc (Documentum), ISI toolbox, Adobe Acrobat Professional & MS Office, Lorenz Validator.
• Knowledge of internal and external publishing standards for US, EU and Canadian Submissions.
• Thorough knowledge of 21 CFR part 11, FDA, GMP, GCP and GLP standards.
Work History
Regulatory Affairs Associate, 08/2022 to 03/2023 Alector, Inc. – Newark, , NJ
Built various submissions within eCTDXPress for NDA and IND applications. Imported submission ready files from an Electronic Document Management System into their specific module folders, file tagging, leaf title modification, bookmarking and hyperlinking, quality assurance and compilation.
Worked on the building, publishing, reviewing and compiling of electronic IND and BLA submissions including Annual Report, DSUR, New Protocols, Protocol Amendments, IND Safety Reports, PADER/PBER, Information Amendments, Investigator Brochures, and various other documents submitted routinely to the FDA.
Gathered, coordinated and submitted to the FDA all IND/BLA maintenance documents (ie, clinical protocols, clinical protocol amendments, pharmacology/toxicology reports, clinical study reports and all post marketing reports and commitments).
Gathers, coordinated and submitted to the FDA all appropriate documents, correspondence and final reports for the US IND and post marketing annual reports.
Regulatory Compliance Specialist, 12/2019 to 12/2020 Catalent Pharma Solutions, Inc. – Kentucky, , Telangana, India
Responsible for the creation of product SDS’s and other safety-related documents covering all commercial and experimental products developed and sold under the various companies owned or affiliated with Bristol-Myers Squibb.
Collected, compiled and documented toxicological, physical, environmental, pharmacological and other scientific data, as well as regulatory information, related to materials.
Perform routine categorizations and calculations for intermediate materials, active pharmaceutical products and formulations.
Performed Hazard classification of materials to comply as per GHS regulations.
Provide customized MSDS formats for appropriate sales markets and maintain multilingual versions as needed through the utilization of SAP.
Maintained the current informational database for all raw materials, formulations, and finished products. Review and evaluate all new and updated supplier MSDS’s and input relevant data into the software database.
Junior RA Associate, 07/2017 to 12/2019 Hetero Biologics – City, , Telangana, India
Reviewed project specifications and designed technology solutions that met or exceeded performance expectations.
Gathered, evaluated, organized, managed and collated information in varying formats.
Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
Prioritized project-related tasks to efficiently complete essential tasks.
Prepared and maintained document inventory for core dossier preparation.
Analyzed product complaints and made recommendations regarding reportability.
Performed and documented quality control checks to maintain compliance with company initiatives.
Prepared and submitted regulatory file applications and supporting documentation.
Maintained and archived regulatory paperwork.
Global Regulatory and Scientific Documentations Intern, 12/2016 to 07/2017 Defence Food Research Laboratory – City, , Karnataka, India
Developed and/or reviewed regulatory documents to ensure that all submissions are complete, accurate, and meet relevant requirements according to ICH and FDA guidelines.
Reviewed and evaluated scientific data, analytical methods and reports required for drug product development and submission in regulatory applications.
Worked with document owners to ensure internal templates and guidelines are used for document creation.-Ensure or perform quality control checking of documents. Includes QC of data, tables, formatting, and style.
Ensured a streamlined process for publishing and document control by developing and maintaining publishing procedures and authoring SOPs where needed.
Education
Master of Science: Biotechnology, Expected in 05/2022 to University of Houston - Clear Lake - Houston, TX GPA:
Bachelor of Technology: Biotechnology, Expected in 07/2017 to Vignan's University - India, GPA:
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Resume Overview
School Attended
University of Houston - Clear Lake
Vignan's University
Job Titles Held:
Regulatory Affairs Associate
Regulatory Compliance Specialist
Junior RA Associate
Global Regulatory and Scientific Documentations Intern