Associate Director, Regulatory Affairs (Remote - Gene Therapy - Strong BLA exp)

Location United States
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Package: Competitive + strong benefits
Contact name: Chris Sinclair

Contact email:
Contact phone: 1 617-982-1238
Job ref: 21391(i)
Published: 9 days ago
Expiry date: 01 May 2021

​Location: Remote, USA

This is a fantastic opportunity for a Regulatory individual to join an innovative, ground-breaking organisation that are truly making a massive impact within the Life Science industry. If you have a true passion for science and want to be part of a cutting-edge organisation to advance Regulatory strategies for novel products, then this is the opportunity for you.

In this role you will be a key team member working closely with cross-functional teams (internally & externally) where you will have the opportunity to provide strategic direction to ensure successful product development and approval. With several products advancing to clinical stage, this position will offer you the opportunity to devise & implement creative regulatory strategies to bring novel products to market quickly, robustly and efficiently. The position provides a fantastic opportunity to apply your current Regulatory knowledge and build experience in the fast growing and advancing field of gene and cellular therapies.

Our client has offices on both the East Coast (Boston) and West Coast (San Francisco), therefore this opportunity offers flexibility between being based in one of the office locations OR working on a remote basis with the ability to travel to the office as and when for relevant meetings.

Skills & Experience:

  • 7+ years of experience in the pharmaceutical or biotech industry.

  • Knowledge and understanding of the pharmaceutical and / or biological product development lifecycle and Regulatory requirements for product development / approval in multiple regions (US, Canada, EU, ROW).

  • Knowledge of late-stage development programs & BLA / MAA submissions.

  • Experience managing stakeholders within Regulatory agencies, with demonstrable skills to develop, communicate and implement successful global regulatory strategies.

  • Preferred but not 100% required – A working knowledge of cellular & gene therapies or biologics development and manufacturing.

  • Bachelor’s degree in a relevant Life Science field (Biology, Chemistry, Pharmacy, Pharmacology etc). An advanced degree (MS / MBA, PhD or MD) would be preferred.

If this sounds like the next step in your Regulatory career, please apply today so that Chris Sinclair can review your profile and be in touch to discuss this further.

Package: Competitive + strong benefits