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- Tasks: Lead global regulatory affairs, ensuring compliance and strategic leadership across projects.
- Company: Join Mantell Associates, a specialist in Pharmaceutical and Life Sciences recruitment.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Be at the forefront of biomedical innovation, making a real impact on healthcare.
- Qualifications: BSc in life sciences or legal discipline; extensive Regulatory Affairs experience required.
- Other info: Work with top regulatory authorities like the FDA and EMA.
The predicted salary is between 43200 - 72000 £ per year.
Senior Manager Global Regulatory Affairs
Mantell Associates is currently partnered with an exciting Biomedical Research organisation, who are looking to bring in a Global Regulatory Affairs Senior Manager to take the company to new heights as they continue to grow.
Responsibilities
- Act as a subject matter expert on global regulatory requirements, including for ATMPs, ensuring company-wide compliance and integrating relevant regulatory intelligence
- Provide strategic and operational regulatory leadership across project teams, including resource allocation, risk identification, and mitigation planning
- Lead regulatory interactions with authorities such as the FDA, EMA, and national agencies, while overseeing the preparation and submission of high-quality regulatory documents (e.g., IMPD/CTA/IND, MAA/BLA, orphan drug and breakthrough designation applications)
- Manage external regulatory service providers to align with business objectives and support the development and maintenance of an effective regulatory affairs function
- Drive internal training, ensure regulatory awareness, and contribute to company policies and governance as the organisation evolves
Qualifications
- BSc or equivalent in a life science or legal discipline, with in-depth Regulatory Affairs experience across the EU and US from early development through to post-approval
- Proven experience with ATMP and/or Rare Disease products, with understanding of HTA requirements, accelerated pathways, and conditional approvals within FDA and EMA frameworks
- Demonstrated success in regulatory strategy development, multi-project leadership, and managing high-level regulatory authority interactions
- Strong leadership, communication, negotiation, and organisational skills, with a track record of creative problem-solving and effective issue management in regulatory contexts
- Familiarity with expedited programs such as breakthrough designation and a collaborative approach to cross-functional engagement
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.
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Senior Manager Global Regulatory Affairs employer: Mantell Associates
Contact Detail:
Mantell Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Global Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with ATMPs and rare diseases. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in global regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks of the FDA and EMA, particularly regarding accelerated pathways and conditional approvals. This knowledge will not only enhance your understanding but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 3
Prepare for interviews by practising how to articulate your past experiences in managing regulatory interactions and leading project teams. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your achievements effectively.
✨Tip Number 4
Showcase your leadership and communication skills by engaging in discussions on platforms like LinkedIn. Share insights or articles related to regulatory affairs, which can help you build a professional presence and attract attention from recruiters in the biomedical research sector.
We think you need these skills to ace Senior Manager Global Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, especially with ATMPs and rare disease products. Use specific examples that demonstrate your leadership and strategic skills.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Mention how your background aligns with their needs, particularly your experience with regulatory interactions and compliance.
Highlight Key Achievements: When detailing your experience, focus on key achievements that showcase your ability to manage high-level regulatory authority interactions and develop successful regulatory strategies.
Showcase Soft Skills: Don’t forget to highlight your soft skills such as communication, negotiation, and problem-solving. These are crucial for a Senior Manager role and should be evident in your application.
How to prepare for a job interview at Mantell Associates
✨Showcase Your Expertise
As a Senior Manager in Global Regulatory Affairs, it's crucial to demonstrate your deep understanding of global regulatory requirements. Be prepared to discuss specific examples of how you've ensured compliance and integrated regulatory intelligence in previous roles.
✨Prepare for Authority Interactions
Since you'll be leading regulatory interactions with authorities like the FDA and EMA, practice articulating your experience in preparing and submitting high-quality regulatory documents. Highlight any successful submissions or interactions you've had with these agencies.
✨Emphasise Leadership Skills
This role requires strong leadership and communication skills. Be ready to share instances where you've led project teams, allocated resources effectively, and identified risks. Use specific examples to illustrate your problem-solving abilities in regulatory contexts.
✨Understand the Bigger Picture
Demonstrate your knowledge of ATMPs and Rare Disease products, as well as expedited programs like breakthrough designation. Show that you understand how these elements fit into the broader regulatory landscape and how they can impact the company's objectives.
