Manager of Regulatory Affairs
Our client, and industry leader in the pharmaceutical industry, is located in New York, NY. They are looking for a Manager of Regulatory Affairs to join their leadership team. Regulatory management is an imperative part of the Interventional Solutions process that this company cannot go without. They are looking for someone to join their team that is dynamic, hardworking, and eager to learn.
What you will do:
- Responsible for the management and completion of activities associated with regulatory filings
- Management of regulatory compliance activities
- Direct correspondence with the FDA to include preparation, submission, liaison, tracking, and maintenance in support of assigned IND's, DMF's, NDA/ANDA's, CTA's, NDS and other correspondence
- Review of both validation and technical documents
What you need:
- PhD in a biological science, chemistry or related field, PharmD or MD
- Master's Degree in a science discipline will be considered
- 6+ years of related experience in regulatory affairs
- 4+ years of direct experience in regulatory affairs will also be considered
- Certification in Regulatory Affairs preferred
- Ability to prepare and translate outlines, summaries, status reports, memos, and other necessary documents
- Experience working with regulatory initiatives from conception to premarket phases
What you get:
- Salary - commensurate with experience
- Excellent benefits package
To be considered, please apply with a resume. If you have any other questions or wish to discuss any other Regulatory Affairs positions, reach out to me directly:
Tamara Thomas // Search Consultant - GPAC // (605)799-4880 // firstname.lastname@example.org
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States over the past 28 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin or protected veteran status.