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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 leadership role.
- Qualifications: 15-20+ years in Regulatory Affairs with proven leadership and negotiation skills.
- Other info: ATMP regulatory experience is a plus; travel required for agency 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 highlight your extensive experience in regulatory affairs, especially within the biotech and pharmaceutical sectors. Emphasize any specific achievements related to regulatory submissions and agency negotiations that demonstrate your capability to lead in this high-impact role.
✨Tip Number 2
Familiarize yourself with the latest guidelines and requirements from regulatory authorities like the FDA and EMA. Showing that you are up-to-date with evolving regulations will position you as a knowledgeable candidate who can drive compliance and strategic influence.
✨Tip Number 3
Prepare to discuss your leadership style and experiences in managing and mentoring regulatory teams. Highlighting your ability to foster an innovative and high-performing environment will resonate well with the expectations for this senior role.
✨Tip Number 4
If you have experience with ATMP regulations or orphan drug development, make sure to bring this up during discussions. This specialized knowledge can set you apart from other candidates and align perfectly with the company's focus on rare diseases.
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: Detail your expertise in GMP, GLP, ICH, and orphan drug development. Mention any specific regulatory submissions you have led, such as INDs or NDAs, to demonstrate your hands-on experience.
Craft a Compelling Cover Letter: Write a strong cover letter that connects your background to the company's mission in rare diseases. Discuss your strategic vision for regulatory affairs and how you can contribute to the company's success.
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 Products and Pipeline
Research the company's marketed products and development pipeline. Be ready to discuss how you would develop and execute regulatory strategies tailored to their specific needs, especially in the rare disease space.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to navigate complex regulatory challenges. Prepare scenarios where you successfully managed regulatory submissions or addressed compliance issues, demonstrating your strategic influence.
