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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 54000 - 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.
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
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.
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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 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 specific examples from your past roles to showcase your leadership and problem-solving skills in regulatory contexts.
✨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 goals during the application process.
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 Targeted CV: Your CV should reflect your expertise in global regulatory requirements and your experience with regulatory interactions. Use specific examples that demonstrate your leadership in managing high-level regulatory authority interactions and your success in regulatory strategy development.
Write a Compelling Cover Letter: In your cover letter, express your passion for the role and the biomedical research field. Highlight your unique qualifications, such as your familiarity with expedited programs and your collaborative approach to cross-functional engagement. Make it clear why you are the ideal candidate for this position.
Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. Ensure that your writing is clear and professional, as attention to detail 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 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 interactions and the outcomes, highlighting your negotiation and communication skills.
✨Discuss Strategic Leadership
This position requires strategic and operational leadership across project teams. Be ready to talk about how you've allocated resources, identified risks, and developed mitigation plans in your previous roles. Use specific examples to illustrate your leadership style.
✨Emphasise Collaborative Engagement
Given the need for cross-functional collaboration, highlight instances where you've worked effectively with different teams. Discuss how you fostered a collaborative environment and contributed to regulatory awareness within your organisation.
