Regulatory Affairs Manager

Highly Competitive Salary
  1. Permanent
  2. Project Manager, Publishing & Submissions, RA Intelligence
  3. United States
Cambridge, USA
Posting date: 02 Sep 2020
RA.JJ.31578

Proclinical is currently recruiting for a Regulatory Affairs Manager with a biotechnology company located in Cambridge, MA.

Job Responsibilities:

  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

Skills and Requirements:

  • Minimum of 6 years in Regulatory Affairs.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
  • Expert knowledge with respect to the respective regulatory landscapes in the US, EU, and Japan.
  • Solid knowledge of GCPs and GLPs.
  • Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 617-830-7544.

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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