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- Tasks: Lead global regulatory strategies and ensure compliance for innovative biomedical projects.
- Company: Join Mantell Associates, a specialist in Pharmaceutical and Life Sciences recruitment.
- Benefits: Enjoy competitive salary, professional development opportunities, and a dynamic work environment.
- Why this job: Be at the forefront of biomedical innovation and make a real impact on global health.
- Qualifications: BSc in life sciences or legal discipline with extensive Regulatory Affairs experience required.
- Other info: Work closely with top regulatory authorities like the FDA and EMA.
The predicted salary is between 43200 - 72000 £ per year.
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.
Senior Manager Global Regulatory Affairs – 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
Senior Manager Global Regulatory Affairs – Requirements:
- 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.
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 expertise 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 expertise in managing regulatory interactions and leading project teams.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Discuss how your background aligns with the responsibilities outlined in the job description, particularly your experience with FDA and EMA submissions.
Showcase Leadership Skills: Emphasise your leadership and communication skills in both your CV and cover letter. Provide examples of how you've successfully led teams or projects in regulatory contexts, highlighting your problem-solving abilities.
Highlight Regulatory Knowledge: Demonstrate your understanding of global regulatory requirements and frameworks in your application. Mention any specific experiences with expedited programs like breakthrough designation and how you have contributed to regulatory strategy development.
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 experiences with ATMPs and how you've ensured compliance in previous roles.
✨Prepare for Authority Interactions
Since you'll be leading interactions with authorities like the FDA and EMA, think of examples where you've successfully navigated these relationships. Highlight your experience in preparing high-quality regulatory documents and any challenges you overcame.
✨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 managed risks. Show how your leadership style fosters collaboration and drives results.
✨Demonstrate Strategic Thinking
Regulatory strategy development is key in this position. Prepare to discuss your approach to developing regulatory strategies, especially for complex products like rare diseases. Illustrate how you've contributed to successful outcomes through strategic planning.