At a Glance
- 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.
- Other info: Work with top regulatory authorities like the FDA and EMA on groundbreaking projects.
- 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.
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 in Coventry employer: Mantell Associates
Mantell Associates is an exceptional employer, offering a dynamic work environment within the innovative Biomedical Research sector. Employees benefit from a culture that prioritises collaboration and professional growth, with ample opportunities for training and development in regulatory affairs. Located in a thriving area for life sciences, the company provides a unique chance to engage with leading regulatory authorities while contributing to groundbreaking advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Global Regulatory Affairs in Coventry
✨Tip Number 1
Familiarise yourself with the latest global regulatory requirements, especially for ATMPs and rare diseases. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, particularly those who have experience with FDA and EMA interactions. Engaging in discussions or attending relevant conferences can provide insights and connections that may benefit your application.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in regulatory strategy development and multi-project leadership. Highlighting your successes in these areas will showcase your capability to lead and innovate within the role.
✨Tip Number 4
Demonstrate your leadership and communication skills by preparing to discuss how you've effectively managed cross-functional teams in previous roles. This will illustrate your ability to drive collaboration and achieve regulatory objectives.
We think you need these skills to ace Senior Manager Global Regulatory Affairs in Coventry
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your relevant experience in regulatory affairs, particularly with ATMPs and rare disease products. Use specific examples to 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. Highlight your strategic leadership skills and provide examples of how you've successfully navigated regulatory challenges in the past.
Showcase Your Knowledge:Demonstrate your understanding of global regulatory requirements by mentioning specific regulations or frameworks you have worked with, such as FDA and EMA guidelines. This will show that you are well-versed in the field.
Proofread Your Application:Before submitting your application, carefully proofread all documents for spelling and grammatical errors. 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 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 that showcase your ability to navigate complex regulatory landscapes.
✨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.
✨Demonstrate Strategic Thinking
Discuss your experience in developing regulatory strategies and managing multiple projects simultaneously. Show how your strategic approach has contributed to successful outcomes, particularly in relation to ATMPs and Rare Disease products, as this will resonate well with the interviewers.
