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- Tasks: Lead regulatory strategy and oversee submissions in a dynamic hybrid role.
- Company: Join TMC Pharma Services Ltd, a leader in pharmaceutical innovation.
- Benefits: Enjoy flexible remote work options and a competitive salary.
- Why this job: Make a significant impact on product development and regulatory processes.
- Qualifications: Experience in regulatory affairs and strong leadership skills required.
- Other info: Opportunity for career growth in a supportive and innovative environment.
The predicted salary is between 43200 - 72000 £ per year.
This is a full-time hybrid role for a Director of Regulatory Affairs at TMC Pharma Services Ltd. The Director will be responsible for leading regulatory strategy development, overseeing regulatory submissions, and providing cross-functional team leadership. While the role is based in Hartley Wintney, there is flexibility for remote work.
Skills and Experience - required:
- Life cycle maintenance of CP licences – additional experience in national, MRP, DCP licences welcomed.
- IND compilation
- Preparation of Module 1 documents
- Able to provide strategic leadership during product development from early stages to MAA.
- Coordination of regulatory procedures such as ODDs, PIPs, scientific advice, PRIME etc.
- Coordination of MAAs including pre-submission activities, Rapporteur meetings, oversight of dossier preparation and submission.
Preferred:
- Ability to author clinical, CMC, or non-clinical documents/modules preferred.
Director of Regulatory Affairs in Fleet employer: TMC Pharma Services Ltd
Contact Detail:
TMC Pharma Services Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Regulatory Affairs in Fleet
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or at events. We can’t stress enough how important it is to make connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory processes. We want you to be able to discuss how your experience aligns with their needs, especially in areas like MAA coordination and IND compilation.
✨Tip Number 3
Showcase your leadership skills! During interviews, share examples of how you've led cross-functional teams or developed regulatory strategies. We believe this will set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Director of Regulatory Affairs in Fleet
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, especially with CP licences and MAAs. We want to see how your skills align with the role, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Director of Regulatory Affairs position. We love seeing passion and clarity, so make it personal and engaging.
Showcase Your Leadership Skills: Since this role involves leading cross-functional teams, highlight any past experiences where you’ve successfully led projects or teams. We’re looking for strategic thinkers who can inspire others!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at TMC Pharma Services Ltd
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory strategies and submissions. Familiarise yourself with the life cycle maintenance of CP licences and be ready to discuss your experience with IND compilation and Module 1 documents. This will show that you’re not just a fit for the role, but that you’re genuinely passionate about regulatory affairs.
✨Showcase Your Leadership Skills
As a Director, you'll need to demonstrate your ability to lead cross-functional teams. Prepare examples from your past where you've successfully guided teams through regulatory processes or product development. Highlighting your strategic leadership during MAAs and other regulatory procedures will set you apart.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges, like coordinating ODDs or PIPs. Think through potential scenarios and how you would approach them. This will help you articulate your thought process and problem-solving skills during the interview.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in TMC Pharma Services Ltd. Inquire about their current regulatory challenges or how they envision the role evolving. This not only demonstrates your enthusiasm but also gives you valuable insights into the company’s priorities.
