Senior Manager, Global Regulatory Affairs

Senior Manager, Global Regulatory Affairs

Location: Hybrid – France (Boulogne)

Employment Type: Full-time

About the Role

We are partnering with a global biopharmaceutical company to support the hire of a Senior Manager within their Global Regulatory Affairs (GRA) team. These hires follow an internal move and a recent resignation, presenting an exciting opportunity to join a growing function with international scope.

As a Senior Manager in Global Regulatory Affairs, you will be accountable for regulatory strategy, submissions, and lifecycle management across global programs. You’ll work closely with cross-functional teams in R&D, franchise, operations, and commercial while acting as a key liaison with health authorities worldwide.

Key Responsibilities

• Develop and implement regulatory strategies for assigned programs at regional or global levels
• Serve as the main regulatory point of contact across internal teams and external regulators
• Provide strategic input into target product profiles, clinical development, and asset plans
• Plan and lead global submissions and regulatory interactions (e.g. Scientific Advice, FDA meetings)
• Identify regulatory risks and develop mitigation strategies
• Monitor regulatory trends and competitor activity relevant to assigned therapeutic areas
• Build relationships with regulators to support long-term strategic alignment
• Drive operational excellence within the regulatory function
• Ensure global compliance and alignment with ethical standards
• Support due diligence efforts for external opportunities

Required Qualifications

• Advanced degree (or equivalent) in a scientific discipline (e.g. Pharmacy, Medicine, Chemistry, Biological Sciences)
• Significant experience in the pharmaceutical industry, including 7+ years in Regulatory Affairs
• Proven ability to lead global regulatory strategy and manage complex projects
• In-depth understanding of ICH, FDA, EMA, and international regulatory frameworks
• Experience preparing and executing global submissions and health authority engagements
• Strong project management, communication, and cross-functional leadership skills

Preferred Qualifications

• Experience in rare diseases, drug-device combinations, or medical devices
• Familiarity with global regulatory frameworks and submission processes
• Prior involvement in external influencing activities or trade associations
• Comfortable working in a hybrid and matrix team environment

Additional Information

• Standard Monday–Friday schedule
• Hybrid model: ~3 days per week onsite in Boulogne, France

This is a unique opportunity to join an organisation focused on innovation and patient outcomes. If you have strong regulatory experience and are looking for your next challenge in a globally visible role, we’d love to hear from you.

Apply now to learn more.