Associate Director, Global Regulatory Strategy

Associate Director, Global Regulatory Strategy (Neurology)

📍 Location: Hatfield, UK (Hybrid – 3 days onsite)

📄 Employment Type: Permanent

Are you an experienced Regulatory Affairs professional looking to play a strategic role in shaping the future of innovative neurology therapies?

We are partnering with a global pharmaceutical organisation seeking an Associate Director, Global Regulatory Strategy to join its international Regulatory Affairs team. This is a high-impact opportunity to influence global regulatory strategy across both development and marketed products while working alongside senior leaders across Europe, the US, and Japan.

This role offers significant visibility within the organisation, the opportunity to represent the company at industry forums and regulatory conferences, and the freedom to help shape future regulatory strategy.

The Opportunity

As Associate Director, you will take ownership of global and/or European regulatory strategy for a diverse neurology portfolio spanning both development and lifecycle management. You'll work cross-functionally with Clinical Development, Medical Affairs, Commercial, and other key stakeholders to develop innovative regulatory approaches that support successful product development and approvals.

This position offers a broad international remit with exposure to multiple markets and the opportunity to contribute to strategic initiatives beyond your core responsibilities.

Key Responsibilities

• Lead global and/or EU regulatory strategies across assigned development and commercial products.
• Develop and execute regulatory submission strategies for CTAs, MAAs, and post-approval activities.
• Lead interactions with health authorities, including scientific advice meetings and regulatory discussions.
• Author and review high-quality regulatory documentation and agency responses.
• Collaborate with global cross-functional teams to align regulatory strategy with clinical development plans and business objectives.
• Drive lifecycle management activities for marketed products.
• Identify regulatory risks and develop proactive mitigation strategies.
• Represent Regulatory Affairs on cross-functional project teams.
• Contribute to process improvements and strategic regulatory initiatives across the organisation.

What We're Looking For

We're interested in speaking with Regulatory Affairs professionals who can demonstrate:

• Extensive pharmaceutical Regulatory Affairs experience within innovative medicines.
• Strong experience supporting drug development programmes.
• Experience developing and executing regulatory strategies.
• Experience leading or contributing to CTA and MAA submissions.
• Experience leading interactions with health authorities, particularly within Europe (EMA experience highly desirable).
• Scientific Advice experience.
• Strong knowledge of European regulatory requirements.
• Excellent written and verbal communication skills.
• Ability to influence senior stakeholders within a global matrix environment.
• Strategic mindset with strong leadership and decision-making capabilities.

Highly Desirable

• Neurology therapeutic area experience.
• Experience across both development and established products.
• Global Regulatory Strategy experience.
• Experience with Paediatric Investigation Plans (PIPs).
• Experience representing organisations at industry or regulatory forums.

Education

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Master's, PharmD or PhD would be advantageous.

Working Environment

• Hybrid working (3 days per week onsite in Hatfield).
• International collaboration across Europe, the US and Japan.
• Approximately 20–30% domestic and international travel.
• Opportunity to work with senior leadership on high-profile development programmes.

Why Apply?

This is an excellent opportunity to join a highly collaborative global Regulatory Affairs team where you'll have genuine influence over regulatory strategy rather than simply executing submissions.

You'll enjoy broad exposure across development and commercial products, meaningful interaction with global health authorities, and the chance to help shape the regulatory direction of innovative medicines in neurology.

If you're looking for your next strategic Regulatory Affairs opportunity, we'd love to hear from you.

📩 Apply today or contact me directly for a confidential discussion.