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Associate Director of Regulatory Affairs in Boston, MA at GPAC

Date Posted: 1/13/2019

Job Snapshot

Job Description

Associate Director of Regulatory Affairs

The pharmaceutical company in Boston, MA that we are working for is one of the best in the area. They are looking for an Associate Director of regulatory affairs to join their leadership team. Regulatory management is an imperative part of the process that this company cannot go without. They are looking for someone to join their team that is dynamic, hard working, and eager to learn.

Associate Director of Regulatory Affairs Responsibilities:

- Responsible for the management and completion of activities associated with regulatory filings

- Management of regulatory compliance activities

- Oversight of regulatory team

- Direct correspondance 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 correspondance

- Review of both validation and technical documents

Associate Director of Regulatory Affairs Qualifications:

- Bachelor's Degree in a science discipline

- Experience with oncology/hematology/biologics

- Advanced Degree in a science discipline would be a huge plus

- 5+ years of regulatory affairs experience

- Certification in Regulatory Affairs preferred

- Experience being a primary author for Regulatory Affairs Documents

If you feel you are qualified for the Associate Director of Regulatory Affairs position and would like to hear more about this opportunity, apply with a resume, or reach out to me confidentially at 605-231-4283 or connor.schultz@gogpac.com.

Please Note: I strive to work in a professional, ethical manner. Although I provide hiring solutions for my clients, I also take many steps to help you reach your professional career goals. Please give me a call or feel free to email me to discreetly discuss this position, as well as others that I know of, that may be potentially stronger than your current situation.

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 27 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.