Regulatory Affairs Strategist
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 growing 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.
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.
· 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 Hannah Oakley or Alex Tosney by email at firstname.lastname@example.org or email@example.com, quoting job ref 49554.
It is essential that applicants hold entitlement to work in the USA.