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- Tasks: Lead global regulatory strategies and ensure compliance across projects.
- Company: Join a dynamic Biomedical Research organisation making waves in the industry.
- Benefits: Enjoy competitive salary, professional development opportunities, and a collaborative work environment.
- Why this job: Be at the forefront of innovative therapies and make a real impact on patient lives.
- 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 48000 - 84000 £ 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.
Locations
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 submissions and interactions with authorities. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your achievements effectively.
✨Tip Number 4
Showcase your leadership skills by discussing examples where you led cross-functional teams or managed external service providers. Emphasise your ability to drive regulatory strategy and foster collaboration, as these are key qualities for a Senior Manager in Global Regulatory Affairs.
We think you need these skills to ace Senior Manager Global Regulatory Affairs
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Senior Manager Global Regulatory Affairs position. Tailor your application to highlight your relevant experience in regulatory affairs, especially with ATMPs and Rare Disease products.
Craft a Compelling CV: Your CV should clearly outline your educational background, particularly your BSc or equivalent in a life science or legal discipline. Emphasise your in-depth Regulatory Affairs experience across the EU and US, showcasing specific projects where you led regulatory interactions with authorities like the FDA and EMA.
Write a Strong Cover Letter: In your cover letter, express your passion for the role and the biomedical research field. Highlight your proven experience in regulatory strategy development and your ability to manage high-level regulatory authority interactions. Use specific examples to demonstrate your leadership and problem-solving skills.
Proofread and Edit: Before submitting your application, take the time to proofread and edit your documents. Ensure there are no grammatical errors or typos, as attention to detail is crucial in regulatory affairs. A polished application reflects your professionalism and commitment to quality.
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 regulatory requirements, especially for ATMPs. Be prepared to discuss specific examples from your past experiences where you successfully navigated complex regulatory landscapes.
✨Prepare for Authority Interactions
Since the role involves leading interactions with authorities like the FDA and EMA, think about your previous experiences in these settings. Prepare to share how you managed these relationships and the outcomes of your engagements.
✨Highlight Leadership Skills
This position requires strong leadership and communication skills. Be ready to provide examples of how you've led project teams, allocated resources effectively, and identified risks in regulatory contexts. Show them your ability to inspire and guide others.
✨Demonstrate Strategic Thinking
The role demands strategic and operational regulatory leadership. Prepare to discuss your approach to developing regulatory strategies and how you've successfully aligned them with business objectives in the past. This will show your potential employer that you can contribute to their growth.
