Senior Regulatory Affairs Associate - Remote Opportunity

About the Role

Kedrion Biopharma UK is seeking a motivated Senior Regulatory Affairs Associate - Remote 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.

Requirements

• 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.
• 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 organization 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.