Senior Regulatory Position in Cambridge
We are seeking a highly motivated and experienced EU Regulatory Affairs Specialist to join our team in Cambridge, UK. In this position, you will support the preparation and submission of regulatory documentation for marketing authorization applications in the UK.
Responsibilities:
* Regulatory Expertise: Provide expertise in preparing and submitting UK national MAA procedures, variations, and renewal procedures, including Module 1, 2, and 3.
* Internal and External Coordination: Coordinate with internal and external contacts, including regulatory authorities, European affiliates, Headquarter, and partners/customers.
* Document Review: Review registration dossiers prior to each submission step during the MAA filing process for in-house developments and licensed products in the UK.
* Launch Support: Support product launch activities.
* Ongoing Activities: Participate in other regulatory-related activities, including variation submissions for UK manufacturing licenses, PIL and SmPC uploads on the eMC website, review and approval of UK packaging materials artworks, tracking of Sunset Clause activities, and assistance in obtaining Certificates of a Pharmaceutical Product and notarization/legalization where required.
The estimated salary for this role is around £50,000 per annum, based on industry standards and location. The company offers a comprehensive benefits package including generous annual leave, pension scheme, and professional development opportunities.