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Associate Director, Global Regulatory Affairs-CMC

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Director Jobs
Country:
United Kingdom
Region:
Oxfordshire
Contract Type:
Permanent
Currency:
£
Salary:
70,000 to 80,000 per annum
Salary Description:
bonus, car allowance, stocks, pension
Posted:
13-Nov-19
Recruiter:
Key People
Job Ref:
24608

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

If this role may be of interest and you feel you have a suitable profile, please do apply and get in touch with Ross Wilson at rwilson@keypeople.co.uk

Closing Date:
12/12/2019

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