Regulatory Affairs Associate - Biopharmaceutical

Job Type:
Regulatory Affairs
Job Category:
Regulatory Executives
Massachusetts, Home-Based
Salary Description:
Great Rates
Job Ref:

My client, a subsidiary of a top 10 Pharmaceutical company, is looking for an enthusiastic Regulatory Affairs Associate to join them on an exciting project that can be based in Boston, Massachusetts - or Remote for a short term, part time contract, perfect to fit around your current engagements.

Who are we looking for?

I am looking to speak to RA Associates who have experience with routine submission work with regards to NDA/ IND and has some Chemistry, Manufacturing Control (CMC) background.

You will be responsible for the preparation, review and oversight routine of eCTD's to the FDA, so previous working experience working alongside the FDA is essential! - You will serve as a Regulatory Agency Liaison for all INDs, NDAs/BLAs and preclearance of promotional materials under accelerated approval.

Main Interfaces...

  • Other Global Regulatory functions including devices, development, CMC, Labeling and Promotion, Operations and Launch Excellence
  • Global R&D Development functions
  • Global Project teams and regulatory subteams
  • Contract Resource organizations
  • Other biopharma groups
  • FDA

So what should you do now?

If you feel that you would be a good fit and feel that we should have a further conversation regarding the position then send me your resume and give me a call! // 646 415 8221

*Referral Scheme*

If you refer a friend or colleague to me that has not been in contact with Barrington James in the past who you would feel would benefit from a conversation and that person gets successfully placed, you will receive $500!

Contact Details:
Tel: 646 415 8221
Contact: Michael Evans

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