sr regulatory affairs associate resume example with 10+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Professional Summary

Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering [Number] years' experience in [Industry] and looking for a challenging new role.

Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.

To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

  • Accounting Regulations
  • Product Issue Resolution
  • Labeling Requirements
  • International Regulations
  • Annual Reports
  • Critical Thinking
  • Document Review
  • Regulatory Documents
  • Regulatory Affairs
  • FDA Compliance
  • Application Filing
  • New Product Development
  • Maintaining Regulatory Compliance
  • Quality Standards
Work History
Sr. Regulatory Affairs Associate, 06/2016 - 03/2019
Bd (Becton, Dickinson And Company) Dallas, TX,
  • Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
  • Prepared and submitted regulatory file applications and supporting documentation.
  • Wrote or updated standard operating procedures, work instructions or policies.
  • Received, researched and resolved consumer inquiries.
  • Developed or tracked quality metrics.
  • Coordinated recall or market withdrawal activities as necessary.
  • Implemented regulatory guidance procedures for [Area of expertise].
  • Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
  • Carried out day-day-day duties accurately and efficiently.
  • Worked flexible hours; night, weekend, and holiday shifts.
  • Performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
  • Maintained energy and enthusiasm in fast-paced environment.
  • Proved successful working within tight deadlines and fast-paced atmosphere.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
Sr. Regulatory Affairs Specialist, 06/2014 - 06/2016
PuraCap Pharmaceutical LLC City, STATE,

· Prepared, reviewed and submitted Original ANDAs, Amendments and Complete responses to the FDA in accordance with the e-CTD specifications.

· Analyzed protocols, methods, method validation reports, batch records and other CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability by the FDA.

· Worked cross-functionally with multiple CMOs and PuraCap’s internal manufacturing sites, project management and R&D department to provide strategic regulatory guidance and ensure timely regulatory submissions.

· Served as a technical lead for eCTD submissions with the ability to troubleshoot and think creatively to resolve the issues internally.

· Proofread and approved OTC and Rx drug labeling components and also prepared OTC labeling specifications in accordance with PuraCap’s Standard Operating Procedures.

· Responsible for GDUFA Self-identification, Establishment Registrations and publishing Drug Listing files through FDA’s Electronic Submissions Gateway (ESG).

· Evaluated changes and conducted gap analysis and implementation plans to assure compliance to latest requirements.

· Assisted in reviewing customer complaints for safety issues; non-conformances and CAPAs for effectiveness and also reviewed 15-Day Alert Reports.

· Mentored other regulatory staff on labeling review, creation of SPLs and drug listings.

· Gained experience in medical device registration and review of advertising and promotional materials for medical devices and cosmetics.

Regulatory Affairs Associate II/III, 02/2012 - 06/2014
Novel Laboratories, Inc. City, STATE,

· Responsible for authoring, compiling, and submitting the Original ANDAs, Amendments, Supplements and Deficiency Responses in accordance with the FDA guidelines in e-CTD format.

· Evaluated and assessed the regulatory impact of changes to the controlled documents and recommended appropriate filing with the FDA.

· Provided regulatory assessment for post approval supplements (CBEs, CBE-30s and PASs) and ensured continuous regulatory compliance for all commercial products.

· Submitted annual reports, quarterly reports and adverse drug event reports to FDA (including 15-day alerts).

· Responsible for all labeling activities – reviewed and approved drug product labels, package inserts and medication guides in accordance with the current FDA labeling requirements; coordinated with printers on quick turnaround times; maintained master label inventory and contributed to the continuous improvement program.

· Responsible for publishing Drug Listing files and Establishment Registrations through FDA’s Electronic Submissions Gateway (ESG).

· Proficient knowledge of PDF publishing (creating bookmarks, hyperlinks and formatting PDFs).

· Interacted directly with the FDA project managers on review status of supplements and labeling deficiencies and their approval timelines.

· Responsible for identifying and analyzing the Reference Listed Drug updates, USP updates and updates on the new Regulatory requirements.

· Mentored regulatory interns on labeling and guidance for post approval changes.

Analytical Chemist/QA QC Reviewer, 05/2008 - 01/2012
Novel Laboratories, Inc. City, STATE,

· Reviewed laboratory documentation (raw material analysis, finished product analysis, in-process and stability testing, cleaning verification data, equipment calibration), SOPs, method validation protocols and reports, stability summary, pre-marketing and post-marketing stability protocols for ANDA filing.

· Reviewed and approved the executed and scale-up manufacturing and packaging batch records to ensure accuracy and cGMP compliance.

· Responsible for handling and tracking closure of Change Controls, Deviations, non-conformances, OOS and also conducted Corrective and Preventative Action (CAPA) investigation based on root cause analysis and verification of CAPA effectiveness.

· Conducted routine internal and external audits to ensure quality and adherence to GLPs and cGMPs and was also responsible for the Supplier Qualification.

· Prepared Annual Product Reviews (APRs) and trend analysis of data.

· Responsible for tracking training requirements for all departments and provided guidance on documentation to employees as needed.

· Developed and validated analytical methods for Dissolution, Assay, Impurities and Residual Solvents for drug substances and finished dosage forms such as tablets, capsules, suspensions and oral solutions.

· Performed raw material testing - residue on ignition, loss on drying, identification by UV and FT-IR and moisture content by Karl-Fischer Autotitrator.

· Performed QC release, in-process, and stability testing of immediate-release, delayed-release, and orally disintegrating tablets using HPLC, GC, and UV Spectroscopy.

· Performed method transfer studies, created and compiled method validation protocols, validation reports and reference standard qualification reports.

· Additional duties included daily calibration of pH Meters and balances and in-house calibration of instruments like Dissolution baths and HPLCs.

Master of Science: Biotechnology, Expected in 06/2007
Rush University - Chicago, IL
Status -
Bachelor of Science: Pharmacy, Expected in 05/2005
Sri Ramachandra Medical College And Research Insti - Chennai, India,
Status -

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Resume Overview

School Attended

  • Rush University
  • Sri Ramachandra Medical College And Research Insti

Job Titles Held:

  • Sr. Regulatory Affairs Associate
  • Sr. Regulatory Affairs Specialist
  • Regulatory Affairs Associate II/III
  • Analytical Chemist/QA QC Reviewer


  • Master of Science
  • Bachelor of Science

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