Director of Drug Regulatory Affairs Resume Example
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DIRECTOR OF DRUG REGULATORY AFFAIRS
Executive Profile
Highly
motivated and result driven Regulatory Affairs professional, with the knowledge
about FDA principles and strategies to be an effective Regulatory representative.
Core Accomplishments
CERTIFICATIONS:
- Regulatory Affairs Certification (RAC-US) - Granted November 2001
- Certified Quality Auditor (ASQ) - Granted December 2016
PUBLICATIONS:
- Mitchel J, V. Hayes, Shatzoff M, Park GD: The Critical Path Initiative Meets Medical Devices. Applied Clinical Trials 2007;16:3; 48-54.
- Shatzoff M, Park G., Verela F: Electronic Submissions. RAPS Focus 2007
Professional Experience
Director of Drug Regulatory Affairs05/2006 to CurrentNovo NordiskDenver , CO
- Authorized FDA contact regarding regulatory activities and applications.
- Resolve issues, inquiries, and deficiency letters with regulators.
- Facilitate and manage company communications with Regulatory Agencies, including management of Agency meetings.
- Oversee the planning, implementation, and tracking of both short and long term projects and coordinate the establishment and execution of specified deliverables.
- Lead regulatory teams with regard to regulatory issues and requirements.
- Develop regulatory strategies for projects.
- Manage submissions to meet timelines.
- Maintain a high level of knowledge of regulations and regulatory processes.
Manager of Drug Regulatory Affairs10/2002 to 02/2006SANOFI-AVENTISCity , STATE
- Prepare, review and maintain applications and submissions, which support New Drug Applications (NDA), Biological License Applications (BLA) and Investigational New Drug Applications (INDs).
- Maintain global electronic databases.
- Participate in project teams for regulatory pathways, strategies and research requirements related to NDA and BLA product lifecycle.
- Write Standard Operating Procedures (SOPs).
- Facilitate training of associates and support personnel.
- Maintain all of the responsibilities of a Drug Regulatory Affairs Specialist.
Senior Associate of Drug Regulatory Affairs12/1999 to 07/2001Ivax Pharmaceutical, Inc.City , STATE
- Facilitate training of associates and support personnel.
- Prepare, review and maintain the CMC sections of Abbreviated New Drug Applications (ANDAs) and FDA response letters in accordance with FDA regulations and regulatory guidelines.
- Advise support groups of documents necessary for inclusion in drug applications/ responses.
Quality Control Microbiologist04/1996 to 09/1998PFIZER, INCCity , STATE
- Conduct studies to support microbiological/ sterility method validation reports and write study reports for new drug applications (NDA).
- Conduct media fill studies and write study reports.
- Conduct sterilization validation studies for terminally sterilized drug products and write study reports.
- Write Standard Operating Procedures (SOPs).
Education
Master of Science Degree of Drug Regulatory AffairsSeptember 2003Long Island UniversityCity, State
Bachelor of Science Degree: BiologyJune 1994Northeastern UniversityCity, StateBiology
Master of SciencepresentLehigh UniversityState
Professional Affiliations
Regulatory Affairs Professional Society (RAPS) - Since 1998
Drug Information Association (DIA) - Since 2002
American Society for Quality (ASQ) - Since 2005
Skills
Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook, Microsoft Powerpoint, Documentum, eCTDXpress, Electronic Gateway Management, ISI Toolbox, SPL Template Management
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Resume Overview
School Attended
- Long Island University
- Northeastern University
- Lehigh University
Job Titles Held:
- Director of Drug Regulatory Affairs
- Manager of Drug Regulatory Affairs
- Senior Associate of Drug Regulatory Affairs
- Quality Control Microbiologist
Degrees
- Master of Science Degree of Drug Regulatory Affairs September 2003
Bachelor of Science Degree : Biology June 1994
Master of Science present
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