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- Tasks: Support regulatory activities and ensure compliance across multiple markets.
- Company: Join Kedrion Biopharma UK, a leader in life-enhancing products.
- Benefits: Hybrid work model, competitive salary, and opportunities for growth.
- Why this job: Make a real impact in the pharmaceutical industry while collaborating with diverse teams.
- Qualifications: Strong attention to detail and interest in regulatory affairs.
- Other info: Dynamic environment with nearly 1000 colleagues and global reach.
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.
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 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
✨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 in the role but also passionate about the industry!
✨Tip Number 3
Practice common interview questions with a friend or in front of the mirror. We need to articulate our experience clearly, especially how it relates to maintaining high-quality dossiers and compliance.
✨Tip Number 4
Don’t forget to follow up after the interview! A quick thank-you email can keep us fresh in their minds and shows our enthusiasm for the Regulatory Affairs Officer position.
We think you need these skills to ace Regulatory Affairs Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Officer role. Highlight relevant experience and skills that match the job description, especially those related to regulatory submissions and compliance.
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 background makes you a great fit for Kedrion Biopharma UK. Keep it concise but impactful.
Showcase Your Teamwork Skills: Since this role involves working closely with cross-functional teams, be sure to mention any collaborative projects you've been part of. We love seeing how you can work well with others to achieve common goals!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you're serious about joining our team at Kedrion Biopharma UK.
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 industry, especially for RoW markets. Familiarise yourself with the specific requirements for submissions and compliance, as this will show your potential employer that you're serious about the role.
✨Showcase Your Team Spirit
Since this role involves working closely with cross-functional teams, be prepared to discuss examples of how you've collaborated in the past. Highlight your ability to communicate effectively with different departments and how you can contribute to a cohesive team environment.
✨Prepare for Technical Questions
Expect to face technical questions related to regulatory submissions and dossier management. Review common scenarios or challenges faced in Regulatory Affairs and think about how you would approach them. This will help you demonstrate your problem-solving skills during the interview.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company's approach to regulatory compliance or how they handle changes in regulations. This shows your genuine interest in the role and helps you understand if the company is the right fit for you.