Global Regulatory Leader - Biosimilars

Pharmacie du Mont SA seeks a Senior Global Regulatory Leader in Nyon to direct regulatory strategies and submissions for biosimilar products across international markets.

This position serves as the central authority for global regulatory affairs within a dynamic Swiss team. The incumbent will drive complex submissions for biosimilar and pharmaceutical products, ensuring compliance and market access in key regions such as Europe and the United States.

Responsibilities

• Develop and implement global regulatory strategies for product registrations, lifecycle management, and market expansion.
• Oversee the preparation and submission of Common Technical Documents (CTDs), variations, renewals, and responses to health authorities.
• Serve as the main point of contact for international agencies, including the EMA, FDA, and other global bodies.
• Partner with R&D, Quality, Manufacturing, Clinical, and Commercial teams to align regulatory efforts.
• Track changing regulatory landscapes and advise internal stakeholders on strategic implications.
• Draft, review, and finalize regulatory documentation and labeling materials.
• Ensure readiness for audits and inspections while supporting broader compliance initiatives.
• Guide junior staff and drive continuous improvement within the Regulatory Affairs department.
• Represent the department in global project teams and external regulatory forums.

Requirements

• Advanced degree in Pharmacy, Life Sciences, or a related scientific field.
• Significant experience in Regulatory Affairs within the pharmaceutical or biotech sectors.
• Deep expertise in biosimilars and managing global regulatory submissions.
• Proven track record of interacting with regulatory authorities in Europe, the US, and other international markets.
• Comprehensive knowledge of ICH, EMA, FDA, and WHO guidelines.
• Strong grasp of drug development, clinical processes, and quality systems.
• Demonstrated ability to lead projects and collaborate across functions.
• Exceptional communication and stakeholder management skills.
• Fluent proficiency in English.
• Capacity to handle multiple priorities in a fast-paced, international setting.

Nice to have

• Proficiency in French or German.

What the company offers

• Chance to work on innovative biosimilar and pharmaceutical products with global reach.
• International and collaborative working environment.
• Strategic role with high visibility across global functions.
• Exposure to complex regulatory projects and worldwide submissions.
• Modern Swiss working environment within a growing and innovation-focused organization.
• Competitive compensation and long-term development opportunities.

About the company

Pharmacie du Mont SA is a globally recognized healthcare organization committed to improving patient outcomes through high-quality medicines and innovative solutions. The company blends scientific excellence, regulatory expertise, and patient-centric innovation to deliver impactful therapies worldwide, fostering a highly collaborative, science-driven environment.

• Dedication to improving patient outcomes through high-quality medicines.
• Combination of scientific excellence and regulatory expertise.
• Patient-centric innovation approach.
• Highly collaborative, science-driven work environment.