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- Tasks: Lead regulatory strategy and oversee submissions in a dynamic pharmaceutical environment.
- Company: Join TMC Pharma Services, a leader in drug development and regulatory affairs.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while tackling unique challenges.
- Qualifications: Experience in regulatory affairs and strong leadership skills required.
- Other info: Collaborate with diverse clients from biotech start-ups to multinational corporations.
The predicted salary is between 54000 - 84000 £ per year.
Company TMC Pharma Services Ltd, based in Hartley Wintney, provides expert support services to the pharmaceutical industry with a focus on drug development, regulatory affairs, consultancy, and post-approval/marketing support. The team excels in delivering successful projects and thrives on tackling unique challenges. TMC collaborates with clients ranging from biotech start-ups to multinational corporations in Europe, the USA, and worldwide.
Role Summary: 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.
- US regulatory experience useful.
Director Of Regulatory Affairs 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
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Director of Regulatory Affairs role.
✨Tip Number 2
Prepare for interviews by researching TMC Pharma Services Ltd thoroughly. Understand their projects and challenges. We want to see you shine by showing how your experience aligns with their needs in regulatory affairs.
✨Tip Number 3
Practice your pitch! Be ready to explain how your skills in life cycle maintenance and regulatory submissions make you the perfect fit. We’re here to help you articulate your value clearly and confidently.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see how you can contribute to TMC’s success in regulatory affairs.
We think you need these skills to ace Director Of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in regulatory affairs. Focus on your achievements in drug development and any specific licences you've managed, as this will show us you're the right fit for the role.
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 align with our needs at TMC Pharma Services. Be sure to mention any relevant projects or experiences.
Showcase Leadership Skills: As a Director, we want to see your leadership style. Highlight instances where you've led cross-functional teams or developed regulatory strategies. This will help us understand how you can guide our team effectively.
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 shows us you’re keen on joining our team!
How to prepare for a job interview at TMC Pharma Services Ltd
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to the pharmaceutical industry. Familiarise yourself with the life cycle maintenance of CP licences and IND compilation, as well as any recent changes in MRP and DCP licences. This will show that you're not just knowledgeable but also proactive about staying updated.
✨Showcase Your Leadership Skills
As a Director of Regulatory Affairs, you'll need to demonstrate your ability to lead cross-functional teams. Prepare examples from your past experiences where you've successfully led a team through regulatory submissions or product development. Highlight how you navigated challenges and achieved results.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory scenarios, such as coordinating MAAs or dealing with scientific advice. Think through potential challenges and your strategies for overcoming them. This will help you articulate your thought process and decision-making 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 projects, challenges they face in regulatory affairs, or how they envision the role evolving. This not only demonstrates your enthusiasm but also helps you gauge if the company is the right fit for you.