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- Tasks: Lead regulatory activities and ensure compliance for innovative pharmaceutical products.
- Company: Join Shionogi, a global leader in healthcare innovation.
- Benefits: Dynamic work environment, growth opportunities, and a chance to impact public health.
- Why this job: Shape the future of healthcare and make a real difference in patients' lives.
- Qualifications: Experience in Regulatory Affairs and strong project management skills required.
- Other info: Collaborative culture with international teamwork and mentorship opportunities.
The predicted salary is between 36000 - 60000 £ per year.
This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.
Shape the Future of Regulatory Excellence with Shionogi. At Shionogi, we are dedicated to protecting the health and well-being of people worldwide. As a global pharmaceutical leader, we are driven by science, innovation, and a deep sense of responsibility to public health. Join us in our mission to deliver life-changing treatments by ensuring robust regulatory strategies and compliance across Europe.
Why Join Shionogi? Shionogi offers a collaborative, agile, and purpose-driven environment where your expertise can make a real impact. We value autonomy, adaptability, and operational excellence. This is a unique opportunity to contribute to a company expanding its footprint in Europe, with a strong focus on regulatory innovation, cross-functional collaboration, and patient-centric solutions.
We are seeking a proactive and experienced Associate Director, Regulatory Affairs to join our team in London. This role offers the chance to lead and shape regulatory activities for our portfolio, ensuring successful product development, approvals, and lifecycle management.
About the Role: You will play a pivotal role in overseeing global and EU regulatory activities for assigned product/s, providing strategic guidance and support to project teams, and ensuring compliance with all relevant regulations. You will work closely with colleagues in Europe, Japan, and the US, leading regulatory submissions, agency interactions, and cross-functional projects.
- Lead and support regulatory submissions (MAAs, Scientific Advice, PIPs) and interactions with European agencies (EMA, MHRA).
- Oversee post-marketing regulatory activities, including variations and lifecycle management.
- Manage CTA strategies and submissions, including vendor oversight.
- Provide regulatory expertise to cross-functional project teams.
- Mentor and guide team members, ensuring best practices and compliance.
- Contribute to the development and optimization of regulatory processes and SOPs.
What Are We Looking For? We are seeking a hands-on and strategic professional who can thrive in a fast-paced, global environment. The ideal candidate will combine technical expertise with strong problem-solving and communication skills.
- Experience in Regulatory Affairs within the pharmaceutical industry, covering both development and marketed products, with demonstrated success of leading or directing an EMA centralised procedure process.
- Strong knowledge of EU regulatory procedures (CP, DCP, MRP) and post-marketing requirements.
- Excellent project management, communication, and interpersonal skills.
- Ability to demonstrate working collaboratively in an international matrix environment, managing multiple priorities.
- Fluency in English (oral and written).
- University degree in life sciences.
Join Us: Join Shionogi and be part of a team that is shaping the future of healthcare with purpose. We offer a dynamic and supportive environment, opportunities for growth, and the chance to make a lasting impact on public health. Apply now and help us ensure that innovative treatments reach the patients who need them most.
Associate Director, Regulatory Affairs in London employer: Shionogi Europe
Contact Detail:
Shionogi Europe Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Regulatory Affairs in London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, webinars, or even local meet-ups. The more you engage, the better your chances of hearing about opportunities that might not even be advertised.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back! Share your insights on regulatory affairs and how you can contribute to their mission. This is your moment to shine and show them why you're the perfect fit.
✨Follow Up Like a Boss
After interviews or networking events, drop a quick thank-you email. It keeps you fresh in their minds and shows your enthusiasm for the role. Plus, it’s a great way to reiterate your interest in shaping regulatory excellence!
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our mission at Shionogi.
We think you need these skills to ace Associate Director, Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Associate Director, Regulatory Affairs role. Highlight your regulatory expertise and any relevant achievements in the pharmaceutical industry to catch our eye!
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 aligns with our mission at Shionogi. Keep it concise but impactful!
Showcase Your Team Spirit: We love collaboration at Shionogi! In your application, mention examples of how you've worked effectively in cross-functional teams. This will show us that you can thrive in our agile environment.
Apply Through Our Website: To make sure your application gets to us directly, apply through our website. It’s the best way to ensure we see your application and consider you for this exciting opportunity!
How to prepare for a job interview at Shionogi Europe
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU regulatory procedures, especially the centralised procedure process. Be ready to discuss your past experiences with MAAs, Scientific Advice, and PIPs, as these will likely come up during the interview.
✨Showcase Your Project Management Skills
Prepare examples that highlight your project management abilities. Think about times when you successfully managed multiple priorities or led cross-functional teams. This will demonstrate your capability to thrive in a fast-paced environment.
✨Communicate Clearly and Confidently
Since communication is key in this role, practice articulating your thoughts clearly. You might be asked to explain complex regulatory concepts, so being able to simplify them will show your expertise and confidence.
✨Be Ready to Discuss Mentorship
As a potential leader, you’ll need to show how you can mentor and guide team members. Prepare to share specific examples of how you've supported colleagues in the past, ensuring best practices and compliance in regulatory affairs.
