Director, Global Regulatory Strategy

Planet Pharma; Hatfield; On-site; GBP 90,000 - 130,000; Full time

Job summary

Planet Pharma in Hatfield, United Kingdom, seeks an experienced Regulatory Affairs leader to guide regulatory activities across the product lifecycle. You will partner with global teams, interact with authorities, and shape strategies for development and commercialization of innovative therapies.

You will develop regulatory strategies for neurology programs, lead CTAs and lifecycle activities, and collaborate with cross-functional teams to ensure successful submissions and ongoing compliance.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree advantageous.
• Extensive Regulatory Affairs experience in biotech/pharma.
• Proven CTA and regulatory submissions experience.
• Experience interacting with European regulatory authorities.
• Understanding of development, registration, lifecycle management.
• Experience creating regulatory strategies for clinical and marketed products.
• Excellent project and stakeholder management.
• Strong written and verbal communication; strategic thinker.

Responsibilities

• Develop and execute regulatory strategies for neurology development programs.
• Lead CTAs, regulatory submissions, variations, and lifecycle activities.
• Serve as regulatory lead on cross-functional teams.
• Interact with European authorities and lead Scientific Advice.
• Provide strategic regulatory guidance throughout development and commercialization.
• Monitor evolving regulatory requirements and assess impact.
• Support global submissions and regulatory interactions.
• Contribute regulatory intelligence to project teams.

Skills

Regulatory leadership

CTA submissions

Regulatory strategy

Project management

Stakeholder management

Global regulatory

Cross-functional

Communication skills

Education

Bachelor's in science

Advanced degree preferred

Job description

This is a highly strategic role focused on guiding regulatory activities throughout the product lifecycle, from clinical development through registration and post-approval maintenance. You'll partner with cross-functional global teams, interact with regulatory authorities, and shape regulatory strategies that support successful development and commercialization of innovative therapies.

Responsibilities

• Develop and execute regulatory strategies for neurology development programs
• Lead and manage Clinical Trial Applications (CTAs), regulatory submissions, variations, and lifecycle activities
• Serve as the key regulatory representative on cross-functional project teams
• Interact directly with European regulatory authorities and lead Scientific Advice procedures
• Provide strategic regulatory guidance throughout development and commercialization
• Monitor evolving regulatory requirements and assess impact on development programs
• Support global submissions and regulatory interactions
• Contribute regulatory intelligence and competitive insights to project teams

Requirements

• Bachelor's degree in a scientific discipline (advanced degree advantageous)
• Extensive Regulatory Affairs experience within the biotech or pharmaceutical industry
• Strong experience with Clinical Trial Applications (CTA) and regulatory submissions
• Proven experience interacting with European regulatory authorities
• Strong understanding of pharmaceutical development, registration, and lifecycle management
• Experience developing regulatory strategies for clinical-stage and marketed products
• Excellent project management and stakeholder management skills
• Strong written and verbal communication skills
• Strategic mindset with strong problem-solving abilities

Preferred Skills

• Experience in Neurology or other specialty therapeutic areas
• Experience acting as a Global Regulatory Lead
• Knowledge of Paediatric Investigation Plans (PIPs)
• Experience supporting global development programs across multiple regions
• Ability to influence cross-functional teams within a global environment

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.