Senior Regulatory Affairs Manager EMENA

Do you have experience in CMC writing? Are you open to exploring a new career opportunity?

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

Role responsibilities: 

The Senior Regulatory Manager will prepare/write, compile and maintain Marketing Authorisation (MA) 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 also be a requirement to support CIS/MENA registrations, such as arranging CPPs.

What we are looking for: 

We are looking for someone with a degree-level qualification in a life science subject, as well as experience in CMC (Chemical, Manufacturing, and Control) writing and a good knowledge and understanding of Module 3. You should also possess the following skills:

• Experienced in pharmaceutical regulatory processes and relevant UK/EU legislation is essential
• Have excellent organisation skills – able to manage multiple tasks to deadlines, think on your feet to solve problems, and maintain a high level of accuracy, even in a changeable work environment
• 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.