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.
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 the ongoing compliance of products across multiple markets.
The position is hybrid, with some on‑site attendance at our Elstree location each month.
About the role
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.
Key responsibilities
* 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.
* Maintain the Global Core Dossier for assigned products.
* 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.
* Create and maintain baseline dossiers for products under responsibility across EU countries.
Skills & qualifications to help you in the role
* A scientific degree in one of the following disciplines:
* Life Sciences (Biochemistry, Biology, Biotechnology)
* Pharmacy (PharmD preferred)
* Pharmacology
* Chemistry
* 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.
* The 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 a regulatory consultancy/CRO environment.
In return we offer
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
* Loyal service awards
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. Our plant is based in Elstree and counts nearly 1000 colleagues across various departments.
Since its foundation, Kedrion has experienced consistent growth, backed by strong performance indicators. Today, the company employs 5,200 people globally who work collaboratively on our portfolio of 38 life-enhancing plasma-derived products distributed in over 100 countries.
Please apply today for immediate consideration!