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.