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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 competitive salary, professional development opportunities, and a dynamic work environment.
- Why this job: Be at the forefront of biomedical innovation, making a real impact on global health.
- Qualifications: BSc in life sciences or legal discipline with extensive Regulatory Affairs experience required.
- Other info: Work with top regulatory authorities like FDA and EMA, shaping the future of healthcare.
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 experience in managing high-level regulatory authority interactions. Use examples from your past roles to showcase your leadership and problem-solving skills, particularly in complex regulatory scenarios.
✨Tip Number 4
Consider reaching out to current or former employees of the organisation to gain insights into their culture and expectations. This can help you tailor your approach and demonstrate your genuine interest in contributing to their mission during the application process.
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: Write a cover letter that showcases your understanding of global regulatory requirements and your experience with FDA and EMA interactions. Explain why you are passionate about the role and how you can contribute to the company's growth.
Highlight Key Achievements: In both your CV and cover letter, include quantifiable achievements related to regulatory strategy development and successful submissions. This will help illustrate your capability and impact in previous roles.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
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 during submissions.
✨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. Show how your leadership style fosters collaboration and drives results.
✨Demonstrate Strategic Thinking
Discuss your approach to regulatory strategy development and how you've managed multiple projects simultaneously. Provide examples of creative problem-solving and effective issue management, particularly in complex regulatory contexts.