Senior Regulatory Affairs Associate

Location
Surrey
Salary
Dependent on Experience
Posted
06 Mar 2019
Closes
03 Apr 2019
Ref
J5630849
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
We are currently looking for a Senior Regulatory Affairs Associate to join a leading Pharmaceutical company based in South West London. As the Regulatory Affairs Manager you will be responsible for Post-Marketing activities of the companies Generic products with a special focus on CMC Technical Transfer.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Regulatory Affairs Associate will be varied however the key duties and responsibilities are as follows:

1. To ensure the successful transfer of products from Global Manufacturing sites to CMO's based in Europe. You will therefore ensure products are compliant to EU regulations.

2. Compile and submit appropriate variations to support drug product manufacturing transfers as well as other variations such as batch release, labelling etc.

3. You will work with packaging development and labelling teams for artwork changes and implementation.

4. Be responsible for overall documentation management to ensure the regulatory team remains compliant.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline e.g. Pharmacology, Chemistry, Biology etc.

2. Proven industry experience in a Regulatory Affairs focused position. Experience of Post Marketing and Life Cycle Management activities (Variations, Renewals, Market extensions) is important for your application.

3. A working knowledge and practical experience with CMC documentation including CMC Variations and CMC writing will be beneficial to your application.

Key Words: Regulatory Affairs | CMC | Post Marketing | Variations | Renewals | Technical Transfer | Generics | Contract | Temporary | Fixed Term | Life Cycle Management

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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