regulatory specialist resume example with 19+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000 - Cell: - - -
Professional Summary

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. Dedicated pharmacy professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

  • 20+ years of delivering presentations and training
  • Excellent researching and writing ability
  • Proven ability to quickly become therapeutic area expert
  • Proven ability to build and maintain professional working relationships
  • Excellent written and verbal communication skills
  • Attention to detail, with multitasking abilities
Work History
10/XXX1 to Current
Regulatory Specialist Apex Systems Fuquay Varina, NC,
  • Interpret regulatory rules or rule changes and communicate with others through policies and procedures.
  • Prepare and submit regulatory file applications and supporting documentation.
  • Perform and document quality control checks to maintain compliance with department initiatives.
  • Prepare and document inventory for core dossier preparation in collaboration with Regulatory Affairs Manager.
  • Recommended improvements to processes, leading to improved collaboration between monitoring unit and regulatory unit for protocol and case record form development.
11/2008 to 08/XXX1
Staff Pharmacist Cvs Health Pittsfield, MA,
  • Performed drug utilization reviews pertaining to prescriptions in therapeutic areas that include: Rheumatoid Arthritis, Immunology, Endocrine, Oncology, Multiple Sclerosis, Hepatitis C, HIV
  • Assessed medication therapy outcomes for autoimmune diseases
  • Performed managed care and coverage review outreach to physician offices
  • Consulted patients on safe and appropriate drug utilization
  • Provided specific, unbiased, and timely responses to healthcare provider requests for drug information
  • Recognized, documented, and reported adverse events and product quality complaints according to policies and procedures
  • Reviewed latest clinical guidelines and new drug therapies
  • Delivered training and presentations on new drug launches
  • Reviewed and updated current Standard Operating Procedures [SOPs]
  • Reviewed and updated Dispensing and Practice Guidelines
  • Performed assessments of turnaround time reports to facilitate completion of aging orders in queues
  • Served as subject matter expert on new processing system, for specialty drugs based on agile technology
  • Performed validation of IT releases in new operating system
  • Delivered biweekly presentations to Rheumatoid Arthritis and Immunology team on system updates and new drug launches
  • Trained newly hired pharmacists on multiple processing platforms, disease states and drug therapies
  • Conducted cross-training sessions for pharmacists
  • Identified system flaws and misinterpretations of therapy regimens to ensure safe and effective patient care
  • Precepted pharmacy students on lifecycle of prescription and therapy related SOPs
08/2002 to 05/2007
Graduate Research Assistant Children's National Medical Center Greenbelt, MD,
  • Provided comprehensive research assistance and support when designing and executing experiments.
  • Prepared materials for reports, presentations and submission to peer-reviewed journal publications.
  • Gathered, reviewed, and summarized literature from scientific journals such as SciFinder and PubMed and produced graphs and other scientific calculations using MS Excel.
  • Planned, modified, and executed research techniques, procedures and tests.
  • Contributed to professionally-written scientific paper for publication.
  • Maintained and calibrated equipment for precision and accuracy.
  • Educated undergraduate students on safe use of lab equipment and reagents and chemicals.
  • Helped team meet regulatory requirements by coordinating documentation and filings.
05/2000 to 07/2002
Clinical and Regulatory Affairs Executive Elder Pharmaceuticals City, STATE,
  • Prepared documents for review/approval and filing of global regulatory submission
  • Evaluated published medical and scientific literature and developed comprehensive standard response documents
  • Wrote and reviewed technical Quality/CMC regulatory documents for global regulatory submissions, ensuring compliance and alignment with global regulatory requirements and strategy
  • Managed, tracked and archived regulatory documents in an information management system
  • Presented key Quality/CMC updates to regulations, guidelines and processes, to project team
  • Provided scientifically accurate, clear and concise medical literature and trained marketing teams
  • Prepared final documents/dossiers on Phase III and post marketing trials and gave presentations to regulatory board
Expected in 05/2007
Ph.D.: Medicinal And Pharmaceutical Chemistry
University of Mississippi - University, MS
Expected in 05/2000
Master of Science: Pharmaceutical Sciences
Mumbai University - Mumbai, India,
Expected in 05/1998
Bachelor of Science: Pharmacy
Mumbai University - Mumbai, India,

Medication Therapy Management (MTM) Certified – American Pharmacists Association [APhA]

Rho Chi Member – Pharmacy Honor Society

Certificate of completion of GCP-ICH guidelines training program

Honors fellowship award, University of Mississippi

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Resume Overview

School Attended

  • University of Mississippi
  • Mumbai University
  • Mumbai University

Job Titles Held:

  • Regulatory Specialist
  • Staff Pharmacist
  • Graduate Research Assistant
  • Clinical and Regulatory Affairs Executive


  • Ph.D.
  • Master of Science
  • Bachelor of Science

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