Global Regulatory Coordinator

5 days ago


Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full time
Regulatory Affairs Job Opportunity in Dr. Reddy's Laboratories

We are looking for a talented EU Regulatory Affairs Specialist to join our team in Cambridge, UK. As a key member of our Regulatory Affairs team, you will be responsible for supporting the preparation and submission of regulatory documentation for marketing authorization applications in the UK.

Main Responsibilities:
  • UK Regulatory Submissions: 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.
  • Registration Dossier Review: 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 Assistance: Assist with product launch activities.
  • Ongoing Regulatory Work: 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 comes with a competitive salary of £47,500 - £57,500 per annum, depending on experience, and a comprehensive benefits package including generous annual leave, pension scheme, and professional development opportunities.



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