Global Regulatory CMC Manager

Location
Berkshire
Salary
£45000 to £55000 per annum
Posted
15 Feb 2018
Closes
15 Mar 2018
Ref
J4949
Contact
Andrew Davis
Sector
Chemistry
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions (HRS) are currently searching for a Global Regulatory CMC Manager to join a pharmaceutical company based in the Berkshire area. As the Global Regulatory CMC Manager you will be responsible for

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Global Regulatory CMC Manager will be varied however the key duties and responsibilities are as follows:

1. Maintain marketing authorisation across a global product portfolio.

2. Project manage CMC documentation for new product development registrations in Global and EU markets.

3. Specialise in Module 3 documentation for company pipeline.

4. As the Global Regulatory CMC Manager, you will compile regulatory documentation for health authority submissions.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Global Regulatory CMC Manager we are looking to identify the following on your profile and past history:

1. Relevant degree in a Chemistry, Biological Sciences or Life Sciences.

2. Detailed experience of submitting regulatory marketing authorisation applications.

3. EU and International territory experience is essential.

Key Words: Regulatory Affairs, Regulatory CMC, Regulatory CMC Manager, Global, Pharmaceutical.

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