Senior Regulatory Affairs Manager

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About the job

Do you have significant experience within Regulatory Affairs – specifically CMC Module 3? Are you interested in stepping in into a more senior position in a global pharmaceutical company specialising in generics?

Invenia Group is currently partnered with a leading international pharmaceutical company, who are seeking a Senior Regulatory Affairs Manager to support the post approval quality and safety changes of various EU markets and registration of drug product in the UK and Europe.

To apply you must be located and have right-to-work in either of these countries:

Belgium, Czechia, Denmark, Finland, France, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, UK

Role responsibilities:

If successful, as the Senior Regulatory Manager you will prepare and write, compile and maintain Marketing Authorisation (MA) submissions, post approval variations (simple, complex, BSVs) and monitor the progression and follow-up with regulatory agencies. To support this activity, you will compile and submit relevant submission packages in accordance with the respective requirement (with the support of the supplier, if applicable) for the administrative, clinical and non-clinical sections for each product. In addition, you there will be a requirement to support CIS/MENA registrations, such as arranging CPPs.

What we are looking for:

An ideal candidate would hold a life science degree and have extensive experience within CMC writing and understanding of Module 3. It is essential that you have great working knowledge of the pharmaceutical regulatory processes and relevant UK/EU legislation within generics.

If you are interested in proceeding with this opportunity, please apply to find out more.