Cpl Life Sciences
Director Global Regulatory Affairs
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Global Regulatory Strategy Director
I'm working with a globally recognised, research-driven pharmaceutical organisation with a strong presence across specialist therapeutic areas. With a patient-centric culture and a commitment to scientific innovation, they are seeking an experienced Global Regulatory Strategy Director, to join their regulatory leadership team.
This is a high-impact position offering the opportunity to influence global development programmes, lead regulatory strategy for innovative neurology assets, and drive interactions with major health authorities worldwide.
The Opportunity
As the Global Regulatory Strategy Director, you will provide strategic regulatory leadership across the development and lifecycle management of neurology products. Acting as the regulatory lead within cross-functional project teams, you will be responsible for developing and executing global regulatory strategies that support successful clinical development, registration, and commercialisation activities.
You will represent Regulatory Affairs at a senior level, collaborating closely with clinical, medical, commercial, and external partner teams while leading interactions with global regulatory agencies.
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Key Responsibilities
- Develop and execute global regulatory strategies for neurology development programmes and commercial products.
- Lead the preparation, review, and submission of Clinical Trial Applications (CTAs), marketing authorisation applications, variations, supplements, and lifecycle management submissions.
- Serve as the regulatory representative on global project teams, providing strategic guidance throughout the product lifecycle.
- Lead interactions and negotiations with international regulatory authorities, including the EMA and other key health agencies.
- Ensure clinical development plans and study designs align with regulatory requirements and evolving guidance.
- Drive proactive regulatory planning to support accelerated development timelines and successful approvals.
- Provide regulatory support for partnerships, collaborations, and business development initiatives.
- Monitor changes in the regulatory landscape and advise internal stakeholders on potential impacts.
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About You
- Significant Regulatory Affairs experience within the pharmaceutical, biotechnology, or biopharmaceutical industry.
- Proven track record developing and leading global regulatory strategies for innovative products.
- Extensive experience with Clinical Trial Applications, submissions, and regulatory maintenance activities.
- Strong experience interacting directly with global regulatory authorities, particularly the EMA.
- Deep understanding of regulations and guidelines governing pharmaceutical development and product registration.
- Experience within Neurology, CNS, or related therapeutic areas is highly desirable.
- Experience with Paediatric Investigation Plans (PIPs) would be beneficial but is not essential.
- Strong leadership, stakeholder management, and cross-functional collaboration skills.
For a confidential discussion and further information, please get in touch directly - jamie.keith@cpl.com
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