Associate Director, Global Regulatory Affairs-CMC

Key People


Job ID :

15363


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

Associate Director, Regulatory Affairs, CMC


Salary :

£70000 - £80000 per annum + bonus, car allowance, stocks, pension


Date Posted :

04 Oct, 2019



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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