Senior Regulatory Affairs Associate - CMC

Dependent on Experience
07 Nov 2018
05 Dec 2018
Georgia Walden
Contract Type
Full Time
We are currently looking for a Senior Regulatory Affairs Associate - CMC to join a leading Biopharmaceutical Manufacturing company based in the Wiltshire area. As the Senior Regulatory Affairs Associate - CMC you will be responsible for providing Regulatory knowledge to ensure the successful completion of CMC focused projects.


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

1. Preparation of CMC documentation for MAA, ANDA, NDA and BLA submissions for National, EU and US markets.

2. To provide Regulatory advice and support at client and pre-filing meetings and assist with areas outside of CMC.

3. To prepare regulatory documentation to support post-approval activities.

4. To write CMC documentation to a high standard in eCTD format including Module 3, Module 2 and preparation of ASMF and CEP certificates for Module 1.


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

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology etc.) in addition to industry experience and / or Knowledge in a Regulatory Affairs setting.

2. Proven industry experience in writing and understanding CMC / Module 3 documentation.

3. A working knowledge and practical experience with eCTD software. Experience with Biologics and Biosimilars is beneficial but not essential.

Key Words: Regulatory Affairs | CMC | Chemistry Manufacturing Controls | Module 3 | ASMF | CEP | CMO | Biologics | Biosimilars | GMP | Stability | Regulatory Affairs Officer | Regulatory Affairs Associate | MAA | BLA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.

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