Regulatory Affairs Strategist

Location
Boston
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
49548
Contact
Amy Lloyd
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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.

Apply:
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.

Apply for Regulatory Affairs Strategist

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.