Vice President of Regulatory Affairs

Expiring today

CK Group
20 Aug 2021
17 Sep 2021
Alex Tosney
Contract Type
Full Time
CK Group are recruiting for a highly motivated and experienced Vice President of Regulatory Affairs to join a cell therapy biotech company, based in Boston, Massachusetts on a permanent basis.

The Company:

Our client is an immunotherapy company located in Waltham MA, established to pioneer the next generation of immunotherapies. They are committed to enabling the world with these transformative reagents in order to accelerate biological discovery and the development of new therapeutics.

VP of Regulatory Affairs Role:
Duties will include:
  • Leading multi-disciplinary teams in the authoring of regulatory communications such as regulatory briefing packages.
  • Working directly with the FDA, and other regulatory agencies (either directly or through vendors), managing preparation for and attendance at assigned meetings, provision of responses etc.
  • Being accountable for submission (either directly or through vendors) of high-quality regulatory packages for CTAs, INDs, with subsequent coordination and provision of responses.

Your Background:
  • Experience in regulatory affairs roles in the biotechnology or pharmaceutical industry.
  • Knowledge of GMPs, GLPs and GCPs.
  • Must have previous experience in leading FDA interactions.
  • Extensive experience of regulatory drug development including product approval/launch.
  • Experience in relevant therapy area (small molecules & biologics) is preferred.

For more information or to apply for this Vice President of Regulatory Affairs position, please contact Alex Tosney by email at, quoting job ref 51470.

It is essential that applicants hold entitlement to work in the USA.

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