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- Tasks: Support regulatory activities for diverse pharmaceutical products in a hybrid role.
- Company: Kedrion Biopharma UK, a leader in the pharmaceutical sector.
- Benefits: Pension, on-site parking, employee discounts, and family-friendly policies.
- Why this job: Join a dynamic team and make a real impact in global regulatory affairs.
- Qualifications: Degree in Life Sciences or Pharmacy and relevant regulatory experience.
- Other info: Collaborative environment with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
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 will 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 will 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:
- Pension
- On-site parking
- Employee assistance programme
- Virtual GP
- Cycle to work scheme
- Subsidised canteen
- Employee discounts and cash back
- Family friendly policies
- Employee recognition programme
Apply today for immediate consideration.
Regulatory Affairs Sr Associate in Elstree employer: Kedrion Biopharma GmbH
Contact Detail:
Kedrion Biopharma GmbH Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Sr Associate in Elstree
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of RoW markets and regulatory processes. We recommend practising common interview questions with a friend to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your attention to detail! During interviews, share specific examples of how you've managed regulatory documentation or coordinated with teams. This will highlight your skills and make you stand out.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining our team at Kedrion Biopharma UK.
We think you need these skills to ace Regulatory Affairs Sr Associate in Elstree
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs role. Highlight your relevant experience in the pharmaceutical sector and any specific projects you've worked on that relate to RoW markets. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can contribute to our team. Be sure to mention any experience with EU or US regulatory activities, as this will catch our eye.
Showcase Attention to Detail: In regulatory affairs, attention to detail is key. When you submit your application, double-check for any typos or errors. We appreciate candidates who take the time to ensure their documents are polished and professional!
Apply Through Our Website: We encourage you to apply directly through our website. This way, your application goes straight to us, and we can review it promptly. Plus, it shows you're keen on joining our team at Kedrion Biopharma UK!
How to prepare for a job interview at Kedrion Biopharma GmbH
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in relation to RoW markets. Familiarise yourself with the specific regulations and guidelines that Kedrion Biopharma UK adheres to, as this will show your genuine interest and preparedness.
✨Showcase Your Collaboration Skills
Since this role involves working with cross-functional teams, be ready to discuss examples of how you've successfully collaborated in the past. Highlight any experiences where you coordinated with different departments or managed stakeholder expectations.
✨Be Detail-Oriented
Attention to detail is crucial in regulatory affairs. Prepare to demonstrate your ability to manage documentation accurately. You might want to bring examples of how you've maintained compliance in previous roles or how you've handled complex regulatory submissions.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the team dynamics, the types of products you'll be working on, or how they measure success in regulatory submissions. This shows your enthusiasm and helps you gauge if the company is the right fit for you.