Key Role in UK Regulatory Affairs
A key position has become available in our UK location for an EU Regulatory Affairs Specialist. As a vital member of our team, you will play a crucial role in supporting the preparation and submission of regulatory documentation for marketing authorization applications in the UK.
Main Responsibilities:
* Preparation and Submission: Prepare and submit UK national MAA procedures, variations, and renewal procedures, including Module 1, 2, and 3.
* Regulatory Coordination: Coordinate with internal and external contacts, including regulatory authorities, European affiliates, Headquarter, and partners/customers.
* Review and Assessment: Review registration dossiers prior to each submission step during the MAA filing process for in-house developments and licensed products in the UK.
* Product Launch Support: Provide support for 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.
This full-time role offers a salary of £45,000 - £55,000 per annum, depending on experience, and benefits package including generous annual leave, pension scheme, and professional development opportunities.