Director Regulatory Affairs
- Employer
- Barrington James
- Location
- United Kingdom
- Salary
- Up to £110,000
- Start date
- 28 Jan 2021
- Closing date
- 27 Feb 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Director/Executive
Job Details
The company
My client are clinical stage biotech developing immune therapies for the treatment of cancer. Their pipeline of first-in-class anti-cancer therapies is based on a unique platform technology enabling the activation of T cells that are specific for immune inhibitory molecules. They have just received £110 million of Series B funding to advance their pipeline which has a range of compounds Pre-Clin to Phase 3.
The role
Responsible for developing innovative global regulatory strategies and working with the cross-functional project team on execution.
Serve as the primary interface for FDA/EMA on assigned projects and prepare the team for meetings with FDA/EMA and other Regulatory Agencies.
Lead and coordinate: CTAs/INDs/MAAs/BLAs/Breakthrough Designation/PRIME
Educates company on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business.
Represent Regulatory Affairs in several internal cross-functional teams, like the project core-team, Clinical Teams and Study Teams, etc. Present and defend regulatory plans to the senior management and project review boards.
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
United Kingdom
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