As part of a period of sustained growth, Diamond BioPharm Ltd have a vacancy available for a Director of Regulatory Affairs with 5+ years biologics experience and preferably with ATMP experience.
The successful candidate will lead clients at the cutting edge of regulatory science with high-profile companies.
Key responsibilities and duties of the role:
- Expert in EU Regulatory Affairs providing world class advice to our clients
- A client facing consultant, leading matrix project teams
- Leads regulatory projects for clients with clinical stage biologics and ATMP programmes
- Expert regulatory documentation author
- Experience in IMPD or IND writing
- Experience in MAA/BLA desirable
- Experience preparing PIPs, Orphan Applications and Scientific Advice Meetings
- Point of contact with regulatory authorities on behalf of clients
Ideally the candidate would be located at one of our UK offices (Harlow, Cambridge and London), but candidates in continental Europe would be considered.
About Diamond BioPharm Ltd.
Diamond Biopharm Limited is a Regulatory Consultancy with fantastic opportunities for Regulatory Professionals helping our pharmaceutical and biotechnology clients to move their products through all stages of development and post-authorisation. Our UK headquarters are in Harlow, with satellite offices in Cambridge and London. We will be opening offices in the EU through 2018, the first in Barcelona and we anticipate that the second EU office will be announced after the relocation of the EMA.