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- Tasks: Lead global regulatory strategy and execution for innovative pharmaceutical products.
- Company: Join a pioneering pharmaceutical company focused on rare diseases and impactful solutions.
- Benefits: Enjoy autonomy, strategic influence, and the chance to shape regulatory operations at a senior level.
- Why this job: This role offers high-impact leadership and the opportunity to mentor a dynamic regulatory team.
- Qualifications: 15-20+ years in Regulatory Affairs with proven success in strategy and submissions.
- Other info: Experience with ATMP regulations is a bonus; work closely with global regulatory authorities.
The predicted salary is between 43200 - 72000 £ per year.
An exciting opportunity for an experienced regulatory professional to take on a high-impact leadership role in an innovative pharmaceutical company specializing in rare diseases. This position is ideal for someone looking for autonomy, strategic influence, and the ability to shape regulatory operations at a senior level.
As Head of Global Regulatory Affairs, you will lead regulatory strategy and execution across the company’s marketed products and development pipeline. You will work closely with regulatory authorities worldwide (FDA, EMA, MHRA, PMDA, etc.), ensuring successful submissions, approvals, and compliance. This role reports directly to the Chief R&D Officer.
Key Responsibilities:- Develop and execute global regulatory strategies for marketed and pipeline products.
- Lead regulatory authority interactions and ensure feedback is incorporated into development plans.
- Oversee regulatory submissions for pre- and post-authorization procedures, including INDs, NDAs, CTAs, Orphan Designations, and Pediatric Investigation Plans.
- Drive regulatory intelligence, ensuring compliance with evolving guidelines and requirements.
- Manage and mentor the regulatory team, fostering an innovative and high-performing environment.
- Support due diligence activities for new asset evaluations in the rare disease space.
- Ensure regulatory documentation (e.g., briefing documents, clinical protocols, DSURs, PSURs) meets high-quality standards.
- 15-20+ years of experience in Regulatory Affairs within biotech/pharmaceuticals.
- Proven track record in regulatory strategy, submissions, and agency negotiations.
- Strong expertise in GMP, GLP, ICH, and orphan drug development.
- Leadership experience in building, managing, and mentoring regulatory teams.
- Excellent communication, negotiation, and problem-solving skills.
- ATMP regulatory experience is a plus.
Seniority level: Director
Employment type: Full-time
Job function: Research
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Head of Regulatory Affairs employer: AL Solutions
Contact Detail:
AL Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in biotech and pharmaceuticals. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory strategy.
✨Tip Number 2
Familiarise yourself with the specific regulatory authorities relevant to the role, such as the FDA, EMA, and MHRA. Understanding their processes and recent changes in guidelines can give you an edge in discussions and demonstrate your proactive approach.
✨Tip Number 3
Showcase your leadership skills by discussing your experience in managing and mentoring teams. Prepare examples of how you've fostered innovation and high performance within your previous roles, as this is crucial for a senior position like Head of Regulatory Affairs.
✨Tip Number 4
Stay updated on the latest developments in rare diseases and orphan drug regulations. This knowledge will not only enhance your expertise but also demonstrate your commitment to the field, making you a more attractive candidate for the role.
We think you need these skills to ace Head of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in Regulatory Affairs, particularly in biotech and pharmaceuticals. Emphasise your leadership roles and any specific achievements related to regulatory strategy and submissions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Discuss your experience with regulatory authorities and how you can contribute to the company's mission in rare diseases.
Highlight Relevant Skills: In your application, focus on key skills such as negotiation, problem-solving, and team management. Provide examples of how you've successfully led regulatory teams and navigated complex submissions.
Showcase Your Knowledge: Demonstrate your understanding of current regulatory guidelines and your ability to adapt to changes. Mention any specific experiences with GMP, GLP, ICH, or orphan drug development that align with the job requirements.
How to prepare for a job interview at AL Solutions
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience in Regulatory Affairs, particularly your track record with submissions and agency negotiations. Highlight specific examples where you've successfully navigated complex regulatory environments.
✨Demonstrate Leadership Skills
As this role involves managing and mentoring a team, be ready to share your leadership philosophy and experiences. Discuss how you've built high-performing teams and fostered innovation in previous roles.
✨Understand the Company's Products and Pipeline
Research the company's marketed products and development pipeline thoroughly. Be prepared to discuss how your regulatory strategies can align with their goals, especially in the rare disease space.
✨Prepare for Regulatory Authority Interactions
Since you'll be leading interactions with regulatory authorities, brush up on your knowledge of the FDA, EMA, and other relevant agencies. Be ready to discuss how you would approach these interactions and incorporate feedback into development plans.
