Director, Regulatory Affairs - FDA Regulated Products

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Consultant / Specialist, Officer /Associate
  3. United States
Boston, USA
Posting date: 11 Feb 2021
RA.EV.35612A

Proclinical is urgently recruiting for a remote Director of Regulatory Affairs of FDA Regulated Products for a CRO. As the RA Director, you will be responsible for interaction with team across a number of development programs.

Job Responsibilities:

  • Develop regulatory strategy for projects including creative solutions to complex problems
  • Knowledge of current regulations, laws and guidance both US and ex-US
  • Ability to take a leadership position on project teams
  • Independent planning, coordination and preparation of document packages for regulatory submissions, such as Pre-IND meeting requests and packages, INDs, CTDs, EOP2, and/or position papers.
  • Independently initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, up to and including travel to, and direct discussions with the appropriate regulatory agency.

Skills and Requirements:

  • A minimum of a BS in Chemistry or Life Sciences
  • A minimum of 6-8 years pharmaceutical and/or medical device industry experience
  • A minimum of 4 years of regulatory affairs in FDA regulated products
  • RAPS certification preferred

If you are having difficulty in applying or if you have any questions, please contact Emma Vagedes-Plavcan at (+1) 347-694-4446 or e.vagedes@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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