Director of Regulatory Affairs

CK Group
22 Dec 2020
19 Jan 2021
Jonathan Hart-Smith
Contract Type
Full Time
CK Science are recruiting for a highly motivated and experienced Director of Regulatory Affairs with an extensive background in therapeutic antibody or small molecule, pharmaceutical clinical development to join a cell therapy biotech company, based in Boston, Massachusetts on a permanent basis. This is high profile position that will play a key role in the future success of an innovative Immuno Oncology Biotech.

The Company:

Based in Boston, this company is a fast growing and exciting Biotech. Using their own innovative technology, they are developing therapeutics Antibodies that will form the next generation of IO treatments. You will be working with "World Class" scientists with a pedigree built from experience and credibility.

Director of Regulatory Affairs Role:
The primary responsibility of this role will be to oversee planning and delivery of a regulatory strategy for lead clinical assets.

Other duties will include:
  • Providing guidance to internal multi-disciplinary teams (Non-Clinical functions, Biostatistics, Medical Affairs, Medical Writing and Pharmacokinetics) on the regulatory requirements to support clinical development.
  • 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.
  • Development of best practices internally to support regulatory documentation readiness, and development and maintenance of regulatory SOPs.

For more information or to apply for this Director of Regulatory Affairs position, please contact Jonathan Hart-Smith by email at, quoting job ref 49514.

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

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