My client, a biopharmaceutical subsidiary of a top 5 pharmaceutical company is looking for an enthusiastic regulatory affairs associate to join them in their Massachusetts office on a full time contracting basis.
Who are we looking for?
I'm looking to speak to people who have at least three years regulatory experience in NDA and IND submissions with a background Chemistry, manufacturing and control (CMC) background.
You will be managing and supporting the preparation of regulatory documentation for eCTD submission, so previous experience working with 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.
- 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
If you're a good fit for the role and feel we should have a conversation regarding the role, send me your resume and give me a call! firstname.lastname@example.org // 646 415 8221
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!