Regulatory Affairs Officer - Pharmaceuticals in Elstree

Kedrion Biopharma UK is looking for a Regulatory Affairs Officer to join our Regulatory Affairs team, supporting activities across our pharmaceutical portfolio with a primary focus on Rest of World (RoW) markets. This role offers the opportunity to work closely with cross‑functional teams and regional Regulatory Affairs colleagues, contributing to regulatory submissions, maintaining high‑quality dossiers, and supporting ongoing regulatory compliance across multiple markets.

The position is hybrid, with some on‑site attendance at our Elstree location each month. As a Regulatory Affairs Officer, you will play a key role in supporting regulatory activities across the product lifecycle. Your work will help ensure that regulatory submissions are prepared accurately, delivered on time, and aligned with applicable regulatory requirements.

You will be involved in both technical and administrative Regulatory Affairs activities, working collaboratively with internal stakeholders and external contacts:

• Support European Regulatory Affairs activities, including registrations, renewals, and variations for assigned products.
• Support EU reportability assessments for change controls and assist with coordination of change control activities, consolidating input from US and RoW Regulatory Affairs where required.
• 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 documentation, data, or samples from relevant departments.
• Review questions and commitments from Regulatory Authorities, coordinating responses with appropriate internal functions.
• Assemble regulatory documentation and manage submissions directly or through local contacts, ensuring agreed timelines are met.
• Monitor the progress of regulatory procedures and keep relevant stakeholders informed.
• Archive regulatory documentation and maintain planning and tracking tools.

Skills & qualifications to help you in the role:

• A scientific degree in one of the following disciplines: Pharmaceutical Science.
• Relevant experience working within a Regulatory Affairs environment in the pharmaceutical sector.
• Experience supporting regulatory activities for Rest of World (RoW) markets, which is the main focus of this role.
• Experience working with pharmaceutical products (biologics experience is not essential).
• A high level of attention to detail and the ability to manage regulatory documentation accurately.
• Exposure to EU and/or US regulatory activities.
• Experience gained within a pharmaceutical organisation or a regulatory consultancy/CRO environment.

We’re looking for highly motivated and experienced people to drive the business forward. In return you’ll be supported in developing your skills with ongoing training and career opportunities.

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.

Kedrion Biopharma is a biopharmaceutical company headquartered in Italy dedicated to collecting and fractionating blood plasma to produce and distribute plasma-derived therapies worldwide. These treatments help manage and prevent rare, ultra-rare, and debilitating conditions, including Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization.

The Kedrion group has numerous legacies within its brand; your employer will be Bio Products Laboratory Ltd, doing business as Kedrion Biopharma UK. Since its foundation, Kedrion has experienced consistent growth, backed by strong performance indicators. Please apply today for immediate consideration!