Pharmaceuticals

Regulatory Affairs Manager EMENA

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About the job

  • Spain

Are you experienced in pharmaceutical regulatory processes? Do you want to work for one of the fastest-growing pharmaceutical countries in the world? 

Invenia Group is partnered with a leading international pharmaceutical company, that is seeking a Regulatory Affairs Manager to support the post approval quality & safety changes of various EU markets and registration of drug product in the UK & Europe. This is a fantastic opportunity to join a growing organisation focused on the professional development of its employees.

Role responsibilities: 

If successful, you will prepare/write, compile and maintain marketing authorisation submissions, post-approval variations (simple, complex, BSVs), 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, there will be a requirement to support CIS/MENA registrations, such as arranging CPPs.

What we are looking for: 

We are looking for someone who is educated to degree level in a life science subject. You should have experience in CMC (Chemical, Manufacturing, and Control) writing and a good knowledge and understanding of Module 3. You should be experienced in pharmaceutical regulatory processes and relevant UK/EU legislation, and have excellent organisation skills, as well as the following:

  • Be a strong communicator with exceptional interpersonal skills (in written and spoken English), able to relate to colleagues and customers at all levels, and navigate cultural differences with ease
  • Work well in a team but also happy to work autonomously – comfortable to use your own initiative and follow set procedures, but also aware of when a problem needs to be escalated
  • Strong numeracy, literacy, and IT skills (i.e. MS Office and ability to learn new systems quickly)

If you are interested in proceeding with this opportunity, please apply so we can arrange a confidential discussion to discuss the position in more detail.