Regulatory Affairs Strategist

07 Jan 2021
06 Feb 2021
Amy Lloyd
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Science are recruiting for a highly motivated and experienced Regulatory Affairs Strategist, ideally with a 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.

Regulatory Affairs Strategist Role:
Responsibilities include but not limited to:
  • Provide global regulatory strategic leadership for drug development projects.
  • Lead and manage the compilation and submission of new INDs/ CTAs, NDA or BLA.
  • Lead cross-functional writing of nonclinical, CMC reports, IND/CTA, NDA or BLA sections, protocols, etc. supporting regulatory submissions etc., as well as write and edit documents as needed.
  • IND maintenance, including routine and more substantial IND amendments.

Your Background:
  • Minimum 15 years' experience in Regulatory Affairs in the Pharmaceutical/Biotech industry.
  • Bachelor's degree in a scientific discipline; advanced degree preferred.
  • Experience preparing FDA pre-IND meetings, IND submissions, IND maintenance and so on; NDA/BLA and MAA preferred.
  • RAC certification from the Regulatory Affairs Professionals Society is a plus.
  • NDA/BLA, MAA experience is a plus.
  • Strong attention to detail and the ability to manage multiple tasks with competing timelines.
  • Ability to represent Regulatory Affairs at team meetings and meetings with strategic partners.
  • Ability to independently solve problems and work cross-culturally demonstrated ability to work as a team player with multi-disciplinary project teams.
  • Proficiency with commonly used word processing, database systems, document management, and other software.

For more information or to apply for this Regulatory Affairs Strategist position, please contact CK Group, quoting job ref 49548.

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

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