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For Companies At a Glance
- Tasks: Lead global regulatory strategy and execution for innovative pharmaceutical products.
- Company: Join a cutting-edge company focused on rare diseases and impactful solutions.
- Benefits: Enjoy competitive salary, performance bonuses, stock options, and remote work flexibility.
- Why this job: Shape regulatory operations and influence the future of healthcare in a high-impact role.
- Qualifications: 15-20+ years in Regulatory Affairs with strong leadership and negotiation skills required.
- Other info: ATMP regulatory experience is a plus; travel may be required for meetings.
The predicted salary is between 72000 - 108000 £ per year.
Client Overview
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.
About the Role
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.
Candidate Profile
- 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.
Compensation & Benefits
- Competitive salary (GBP), reflecting the seniority of the role.
- 20-25% performance-based bonus.
- Stock options.
- Remote flexibility with travel as required for regulatory agency and company meetings.
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
Make sure to stay updated on the latest regulatory guidelines and trends in the pharmaceutical industry, especially those related to rare diseases. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in regulatory affairs through industry conferences or online platforms like LinkedIn. Building relationships with others in the field can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in regulatory strategy and submissions during interviews. Highlighting your successes and how you've navigated complex regulatory environments will set you apart from other candidates.
✨Tip Number 4
Familiarize yourself with the regulatory authorities relevant to the role, such as the FDA and EMA. Understanding their processes and expectations will help you articulate how you can effectively lead regulatory interactions and ensure compliance.
We think you need these skills to ace Head of Regulatory Affairs
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly understand the responsibilities and requirements of the Head of Regulatory Affairs position. Tailor your application to highlight your relevant experience in regulatory strategy, submissions, and agency negotiations.
Highlight Leadership Experience: Emphasize your leadership experience in managing and mentoring regulatory teams. Provide specific examples of how you have fostered high-performing environments and driven successful regulatory outcomes.
Showcase Regulatory Expertise: Clearly outline your expertise in GMP, GLP, ICH, and orphan drug development. Mention any specific regulatory submissions or interactions with authorities like the FDA or EMA that demonstrate your capability in this area.
Craft a Compelling Cover Letter: Write a strong cover letter that not only summarizes your qualifications but also conveys your passion for working in the pharmaceutical industry, particularly in rare diseases. Make sure to connect your personal values with the company's mission.
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 in biotech and pharmaceuticals. Highlight specific examples of successful submissions and negotiations with regulatory authorities like the FDA and EMA.
✨Demonstrate Leadership Skills
Since this role involves managing and mentoring a regulatory team, share your leadership experiences. Discuss how you've built high-performing teams and fostered an innovative environment in previous positions.
✨Understand the Company's Focus
Research the company's specialization in rare diseases and be ready to discuss how your background aligns with their mission. Show enthusiasm for contributing to their regulatory strategy in this niche area.
✨Prepare for Strategic Discussions
Expect questions about developing and executing global regulatory strategies. Be ready to articulate your approach to incorporating feedback from regulatory authorities into development plans and ensuring compliance with evolving guidelines.
