Associate Director, Global Regulatory Strategy
đź“Ť Hertfordshire, UK (Hybrid: 3 days office-based)
| 🌍 Global Role | 💼 Permanent
Are you ready to shape global regulatory strategies for innovative therapies in neurology?
We’re seeking an Associate Director, Global Regulatory Strategy to join a collaborative clinical research and innovation team supporting the development and lifecycle management of our neurology portfolio.
In this influential role, you’ll lead or support regulatory strategy across multiple regions, ensuring successful submissions, compliance, and long-term product success. You’ll also contribute to early-stage innovation activities — assessing external platforms, technologies, and assets from a regulatory perspective to inform strategic investment and partnership decisions.
You’ll work closely with global colleagues across the UK, US, and Japan to drive regulatory excellence and deliver meaningful outcomes for patients worldwide.
What you’ll do
* Lead Regulatory Strategy: Develop and implement global and regional regulatory strategies supporting clinical development and marketed products.
* Regulatory Due Diligence: Provide regulatory insight during due diligence activities for new platforms, technologies, and in-licensing opportunities, identifying potential risks, opportunities, and pathways to approval.
* Manage Submissions: Oversee preparation, review, and delivery of high-quality regulatory submissions (CTA/MAA) in alignment with timelines and business priorities.
* Regulatory Authority Interaction: Serve as the primary contact with European health authorities (EMA, MHRA, etc.), leading meetings and authoring Scientific Advice requests.
* Lifecycle Management: Drive post-approval activities and product lifecycle strategies to ensure continued compliance and access.
* Collaboration & Compliance: Partner with cross-functional teams to ensure regulatory standards, ethical behavior, and compliance with applicable laws and guidelines.
* Innovation Support: Work within the innovation team to scope new assets and contribute regulatory perspectives to early clinical or preclinical development planning.
What you’ll bring
* A degree in Life Sciences (Master’s, PharmD or PhD preferred) with significant regulatory and pharmaceutical experience.
* Proven track record developing and executing global regulatory strategies and leading submission activities.
* Hands-on experience interacting with European health authorities, including Scientific Advice and Paediatric Investigational Plans.
* Demonstrated experience in regulatory due diligence for new assets or business development opportunities.
* Strong leadership within matrixed, cross-functional environments, with excellent communication and strategic thinking skills.
Why join us
You’ll join a high-performing, inclusive team dedicated to advancing neuroscience innovation. We value diverse perspectives and empower our people to contribute their expertise, learn continuously, and make a tangible difference in global patient health.
Tshering Sherpa
Tsherpa@planet-pharma.co.uk