Director, Regulatory Affairs, Oncology

CK Clinical are recruiting for a Director, Regulatory Affairs, Oncology to join a Global Pharmaceutical Company at their site based in Hertfordshire on a permanent basis.

Director, Regulatory Affairs, Oncology Role:
Main purpose of the job:

- Global Regulatory Lead on International Project Teams and to lead the global Regulatory Sub-team.
- Direct regulatory strategy and contributes to its outcome for the assigned projects/products, e.g. contributions to CDP, DDP, Life Cycle Management Plan, GRASP etc, to deliver a competitive product label, identify opportunities for early market access and identifying/managing regulatory issues and risks.

Your Background:
Qualifications and education required:

- College or University degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology or Pharmacology).
- Doctorate degree desired (e.g. MD, JD, Pharm D, or PhD in life sciences), advanced degree preferred (e.g. RPh).

Experience required:

- Strong EU regulatory experience and a good understanding of US regulatory processes.
- Experience of both early and late phase drug development process.
- Experience in the oncology therapeutic area.
- Extensive submission experience (MAAs, CTAs, scientific advice requests, PIPs, OMPD applications etc.).

Apply:
For more information or to apply for this Director, Regulatory Affairs, Oncology position, please contact CK Group, quoting job ref 48936.

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