At a Glance
- Tasks: Lead regulatory projects and provide strategic advice to clients in drug development.
- Company: Join a prestigious global consultancy specializing in advanced therapies and drug development.
- Benefits: Enjoy a competitive salary of £130,000 plus benefits and hybrid work options.
- Why this job: Make a real impact in the pharma industry while working with innovative therapies and expert teams.
- Qualifications: Experience in regulatory affairs and strong leadership skills are essential for this role.
- Other info: This is a full-time, permanent position based in Cambridge, UK.
The predicted salary is between 78000 - 182000 £ per year.
Job Description Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Location: Cambridge, UK – Hybrid Remuneration: £130,000 + Benefits Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities. The business has a specific focus on advanced therapies, cell therapy, ATMPS, and other niche and challenging therapeutic areas. As the Senior Director of Regulatory Affairs, you will provide support to the Regulatory Affairs team across a range of projects. You will work closely with the Vice President of Regulatory Affairs to oversee the team. Responsibilities for this role include: Lead client projects, providing strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives and early market access (such activities will include gap analyses, advice on filing routes, timings, regulatory authority interactions, paediatric development, orphan drug designation and PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications). Preparation of regulatory submission docu…
Senior Director Regulatory Affairs employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with advanced therapies and niche therapeutic areas. Attend industry conferences and seminars to meet potential colleagues and learn about the latest trends.
✨Tip Number 2
Familiarize yourself with the specific regulatory guidelines and frameworks relevant to cell therapy and advanced therapies. This knowledge will not only enhance your expertise but also demonstrate your commitment to the role during discussions.
✨Tip Number 3
Consider reaching out to current or former employees of the consultancy to gain insights into the company culture and expectations for the Senior Director role. This can help you tailor your approach and show that you understand their unique environment.
✨Tip Number 4
Stay updated on recent developments in regulatory affairs, particularly regarding orphan drug designation and breakthrough therapy designations. Being well-informed will allow you to engage in meaningful conversations and showcase your expertise during interviews.
We think you need these skills to ace Senior Director Regulatory Affairs
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Director of Regulatory Affairs. Understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulatory affairs, particularly in advanced therapies and drug development. Use specific examples that demonstrate your strategic advice capabilities and project leadership.
Showcase Your Skills: Clearly outline your skills related to regulatory guidelines, client interaction, and project management. Mention any relevant certifications or training that align with the requirements of the position.
Craft a Compelling Cover Letter: Write a personalized cover letter that connects your background to the needs of the consultancy. Discuss your passion for regulatory affairs and how you can contribute to their mission of supporting pharma and biotech companies.
How to prepare for a job interview at Cpl Life Sciences
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulatory frameworks relevant to advanced therapies and cell therapy. Be prepared to discuss how these regulations impact drug development and your strategic approach to navigating them.
✨Showcase Leadership Experience
As a Senior Director, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully led teams or projects in the past, particularly in regulatory affairs, and how you managed challenges along the way.
✨Prepare for Strategic Discussions
Expect to engage in discussions about strategic regulatory advice. Think about specific scenarios where you provided guidance on filing routes or market access strategies, and be ready to share your thought process.
✨Familiarize Yourself with Current Trends
Stay updated on the latest trends and changes in regulatory affairs, especially concerning orphan drug designation and breakthrough therapy designations. Being knowledgeable about current events will show your commitment to the field.