CMC Regulatory Affairs Officer

North West
Dependent on Experience
18 Jun 2018
16 Jul 2018
Georgia Walden
Contract Type
Full Time
We are currently looking for a CMC Regulatory Affairs Officer to join a leading Biopharmaceutical company based in the in the North West are of the UK. As the CMC Regulatory Affairs Officer you will be responsible for submission preparation for Biologic products to the US and EU markets. You will focus on CMC regulatory activities as well as clinical CMC projects and market applications.


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

1. Agreed strategy for minor/routine submissions and query any deviations.

2. Track progress against regulatory strategy time-lines for submissions and alert leadership to potential discrepancies.

3. Coordinate and compile documentation needed for licence renewal applications.

4. Communicate, prepare and coordinate Regulatory Affairs requests with the Quality and any other relevant departments.


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

1. Relevant degree in a Scientific discipline 9e.g. Pharmacology, Biology, Chemistry etc.) in addition to industry experience preparing Module 3 documentation for the US and / or EU.

2. Proven industry experience in a CMC field, showing a strong understanding of QA activities and cGMP compliance for licensed Pharmaceutical products.

3. A working knowledge and practical experience managing multiple projects with a good regulatory writing experience.

Key Words: Regulatory Affairs , CMC , Module 2.3 , Module 3 , Regulatory Applications , Licensed products , Biopharmaceutical , Pharmaceutical , GMP , FDA , MHRA , EMA , Submissions , MRP , DCP

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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