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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 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 highlight your extensive experience in regulatory affairs, especially within the biotech and pharmaceutical sectors. Tailor your discussions to showcase specific examples of successful regulatory submissions and negotiations with agencies like the FDA or EMA.
✨Tip Number 2
Demonstrate your leadership skills by discussing how you've built and mentored teams in previous roles. Share insights on how you foster a high-performing environment, as this is crucial for the Head of Regulatory Affairs position.
✨Tip Number 3
Stay updated on the latest regulatory guidelines and requirements, particularly those related to rare diseases and orphan drug development. Being knowledgeable about current trends will help you stand out during discussions with our team.
✨Tip Number 4
Prepare to discuss your strategic vision for regulatory affairs in a rapidly evolving industry. Think about how you can contribute to shaping our regulatory operations and align them with our innovative approach to 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 Relevant Expertise: Make sure to showcase your expertise in GMP, GLP, ICH, and orphan drug development. Mention any specific projects or achievements that demonstrate your knowledge and skills in these areas.
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. Explain why you are excited about the opportunity to shape regulatory operations at a senior level.
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 scenario-based questions that assess your problem-solving and negotiation skills. Think about past challenges you've faced in regulatory affairs and how you successfully navigated them, particularly in relation to compliance and evolving guidelines.
