Job Description
Regulatory Affairs Sr Associate
Posting Start Date:
3/10/26
Country/Region:
United Kingdom
State/Province:
Job Location:
Elstree
Place of Employment:
Hybrid
Contract Duration:
Permanent
Regulatory Affairs Sr Associate
Job Summary
Kedrion Biopharma UK is seeking a motivated Regulatory Affairs Officer to support regulatory activities across our diverse pharmaceutical portfolio, with a primary focus on Rest of World (RoW) markets. In this hybrid role based in Elstree, you'll collaborate with cross‑functional and global teams to prepare high‑quality submissions, maintain compliant dossiers, and contribute to the ongoing regulatory success of our products throughout the lifecycle.
What you'll do
- Support European Regulatory Affairs activities including registrations, renewals, and variations for assigned products.
- Assist with EU reportability assessments for change controls and coordinate change control activities, consolidating input from US and RoW Regulatory Affairs where required.
- Maintain Global Core Dossiers and baseline dossiers across EU countries for products under responsibility.
- Provide Regulatory Affairs product support to internal teams and EU local contacts, including project teams, GMP inspections, and PSUR/RMP activities.
- Prepare technical and administrative sections of regulatory dossiers and request required documentation, data, or samples from internal departments.
- Review questions and commitments from Regulatory Authorities and coordinate accurate responses with relevant internal functions.
- Assemble regulatory documentation and manage submissions directly or through local contacts to meet agreed timelines.
- Monitor regulatory procedure progress and keep stakeholders informed throughout.
- Archive regulatory documentation and maintain planning and tracking tools to support compliant regulatory operations.
Qualifications and need-to-know
- Scientific degree in Life Sciences, Pharmacy (PharmD preferred), Pharmacology, Chemistry, or Pharmaceutical Science.
- Relevant experience within a Regulatory Affairs environment in the pharmaceutical sector.
- Experience supporting regulatory activities for Rest of World (RoW) markets.
- Experience working with pharmaceutical products.Strong attention to detail and the ability to manage regulatory documentation accurately.
- Ability to work collaboratively with multiple stakeholders and manage priorities effectively.
- Exposure to EU and/or US regulatory activities.
- Experience gained within a pharmaceutical organisation or regulatory consultancy/CRO.
What we offer
- Competitive salary
- Annual bonus scheme
- 25 days holiday (plus bank holidays)
- Pension
- On-site parking
- Employee assistance programme
- Virtual GP
- Cycle to work scheme
- Subsidised canteen
- Employee discounts and cash back
- Gym membership discounts
- Family friendly policies
- Employee recognition programme
- Loyal service awards
Apply today for immediate consideration.