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Associate Director, Global Regulatory Affairs-CMC

Oxfordshire   •  £70000 - £80000 per annum + bonus, car allowance, stocks, pension  •  Permanent, Full time


My client, a medium sized bio-pharmaceutical company in the Oxfordshire area,is looking for an Associate Director of Global Regulatory Affairs (CMC).

This will be open as a permanent role and working across regulatory submissions , late and early stage and leading multi-disciplinary teams in essential business projects.

Responsibilities:

-Planning and coordinating the authoring/reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions

-Provide in-depth reviews of protocols, reports, presentations and preempting internal/external business challenges or regulatory issues.

-Interpret complex technical or supply issues for commercial/development programs

-Regular interaction with functional leaders/major customers

-Development of departmental strategy

-Monitor EU and US CMC Regulations

Candidate Profile:

- Applicable knowledge of CMC regulatory

- eCTD CMC regulatory documents (MAA, BLA, Variations, Responses, CTAs/INDs)

- FDA, EMA and ICH guidelines

Education:

- BSc/BA with a minimum of eight years of regulatory CMC experience


You must be eligible to work in the UK. Learn more

  • Agency: Key People
  • Reference: 24608
  • Posted: 4th October 2019
  • Expires: 1st November 2019

Key People

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