Regulatory Affairs Officer

Location
Greater London
Salary
Dependent on Experience
Posted
26 Sep 2019
Closes
24 Oct 2019
Ref
J5631684
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
We are currently looking for a Regulatory Affairs Officer to join a leading Generics Pharmaceutical company based in the Heathrow area. As the Regulatory Affairs Officer you will be responsible for the preparation, review and authorisation of CMC documentation. You will work on new MA submission as well as the variation and renewal of the company's existing portfolio.

This position would suit a Regulatory professional with exposure CMC documentation who is looking to gain experience in authoring Module 3 documentation or an experienced CMC Regulatory professional who is looking to develop in their career.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Prepare, review and authorise CMC (Module 3) documents for Generic products including in-licensed products.

2. Prepare, review and publish different variation including Type 1A, Type 1B and Type 2 including the transfer of National licences to EU procedures including MRP and DCP.

3. Provide regulatory advice to support the UK & EU strategy as well as supporting external clients.

4. Support a small team of Regulatory Affairs Assistants and Associates to ensure internal and external Regulations are maintained.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline (e.g. Pharmacology, Pharmacy, Chemistry etc.) in addition to experience in a Regulatory Affairs environment.

2. Proven industry experience with CMC (module 3) documentation including the handling of a variety of variations and renewals.

3. A working knowledge and practical experience with pre-approval activities such as Dossier review would be beneficial to your applications.

Key Words: Regulatory Affairs | Module 3 | CMC | Variations | Renewals | eCTD | Regulatory submissions | MRP | DCP | Pre-approval | Generics | Pharmaceutical | EU | UK | Post Approval | MAA Submission

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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