Job Title: Director, Global Regulatory Affairs
Location: Hertfordshire, UK (Hybrid, 3 days onsite)
Job Type: Permanent, Full-Time
Package: Competitive salary + bonus, car allowance, private healthcare, pension, life assurance
An exciting opportunity has arisen for an experienced Regulatory Affairs leader to join a global pharmaceutical company with a strong presence in Oncology and Neurology. This strategic role will lead the development and execution of global regulatory strategies, driving assets from early development through to approval and lifecycle management.
As the Regulatory lead, you will play a key role in shaping end-to-end regulatory strategy, leading interactions with global health authorities, supporting major submissions, and driving successful outcomes for Marketing Authorisation Applications (MAAs), Clinical Trial Applications (CTAs), and lifecycle activities. Experience with Paediatric Investigation Plans (PIPs) will be highly advantageous.
Key Responsibilities
- Lead and execute global regulatory strategies across Neurology programmes.
- Provide strategic regulatory leadership to cross-functional project teams throughout the product lifecycle.
- Act as the primary regulatory contact for global health authorities, including the EMA and other international agencies.
- Drive and oversee major submissions, including MAAs, CTAs, variations, supplements, and amendments.
- Lead regulatory aspects of PIP development, submission, and negotiation where applicable.
- Develop regulatory pathways and agency engagement strategies to accelerate approvals and minimise development risk.
- Ensure clinical development plans and trial designs meet evolving global regulatory requirements.
- Provide expert guidance on regulatory requirements, product development, and registration strategies.
Requirements
- Bachelor’s degree in a relevant scientific discipline.
- Significant Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Proven track record of developing and leading global regulatory strategies for innovative products.
- Extensive experience leading MAA submissions and Health Authority interactions, particularly with the EMA.
- Experience with Clinical Trial Applications (CTAs) and regulatory maintenance activities.
- Knowledge of Paediatric Investigation Plans (PIPs) is highly desirable.
- Strong understanding of global regulatory frameworks governing pharmaceutical development and registration.
This is an excellent opportunity for a senior regulatory professional seeking a highly visible strategic position with significant influence on global development and registration activities.
Sponsorship is not available, and applicants must have the right to work in the UK.
…