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- Tasks: Support regulatory activities and ensure compliance across multiple markets in a dynamic team.
- Company: Join Kedrion Biopharma, a leading biopharmaceutical company dedicated to life-enhancing therapies.
- Benefits: Enjoy competitive salary, annual bonus, 25 days holiday, and various employee perks.
- Why this job: Make a real impact in global health while developing your skills in a supportive environment.
- Qualifications: Scientific degree and experience in Regulatory Affairs within the pharmaceutical sector.
- Other info: Hybrid role with excellent career growth opportunities and a collaborative culture.
The predicted salary is between 36000 - 60000 £ per year.
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.
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.
- 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:
- 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!
Regulatory Affairs Officer in Elstree employer: Kedrion Biopharma UK
Contact Detail:
Kedrion Biopharma UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer in Elstree
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Kedrion Biopharma UK on LinkedIn. A friendly chat can give us insider info about the company culture and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of regulatory affairs, especially in RoW markets. We want to show that we’re not just interested but also knowledgeable about the role and its challenges.
✨Tip Number 3
Practice common interview questions related to regulatory submissions and compliance. We can even do mock interviews with friends to build confidence and refine our answers.
✨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 we’re serious about joining the team at Kedrion Biopharma UK.
We think you need these skills to ace Regulatory Affairs Officer in Elstree
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Officer role. Highlight relevant experience, especially in RoW markets, and showcase your scientific background. We want to see how your skills align 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 you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Attention to Detail: In regulatory affairs, attention to detail is key. Make sure your application is free from typos and 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 for the best chance of getting noticed. It’s straightforward and ensures your application goes straight to us. Don’t miss out on this opportunity!
How to prepare for a job interview at Kedrion Biopharma UK
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to the pharmaceutical sector, especially for Rest of World markets. Familiarise yourself with the specific requirements for regulatory submissions and compliance, as this will show your potential employer that you're serious about the role.
✨Showcase Your Collaborative Skills
Since this role involves working closely with cross-functional teams, be prepared 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, as this will demonstrate your ability to work effectively in a team environment.
✨Attention to Detail is Key
Regulatory Affairs requires a high level of accuracy, so be ready to talk about how you ensure precision in your work. Bring examples of how you've maintained high-quality dossiers or managed regulatory documentation, as this will illustrate your meticulous nature and commitment to compliance.
✨Prepare Questions for Them
Interviews are a two-way street, so think of insightful questions to ask about the company's regulatory processes or team dynamics. This not only shows your interest in the role but also gives you a chance to assess if the company culture aligns with your values and work style.