Senior RA Manager (CMC)

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About the job

Do you have experience in CMC writing and extensive experience in Module 3 writing and reviewal? Are you open to exploring new career opportunities?

Invenia Group is partnered with a leading international pharmaceutical company, who are seeking an experienced and driven professional to take on the role of Senior Regulatory Manager and join this exciting and growing team of experts.

Key responsibilities:

The Senior RA Manager is responsible for overseeing the writing and reviewal of EU regulatory affairs activities in relation to Marketing Authorisation and post approval variations and offer support for the CIS and MENA registrations as required too.

  • Support in the post approval for quality & safety changes relating to the registration of drugs in
    the EU markets.
  • Write and review MA and post approval variations (simple, complex, BSVs), while acting as a
    point of contact for the Regulatory Agencies.
  • Submissions relating to the respective requirement for administrative, clinical and non-clinical
    sections for each of the products.
  • Offer support for the CIS and MENA registrations e.g. Arranging CPPs

What we are looking for:

The ideal individual will have excellent organisation skills, with a keen eye for detail, while demonstrating the ability to solve problems within a certain deadline. We are looking for someone with experience in CMC writing and extensive experience in Module 3 writing and reviewal. You should have a proven knowledge within the EU regulatory market, be good with numeracy, literacy and IT (i.e. MS Office and able to learn new systems quickly) and have a degree-level qualification in a life science subject.

If you are interested in proceeding with this opportunity, please apply to discuss the position in more detail.