Global Regulatory Leader - Biosimilars

Pharmacie de la Place du Cirque SA seeks a Senior Global Regulatory Leader in Nyon to direct biosimilar registration strategies and manage complex international submissions for Europe and the US.

This senior position is responsible for defining and executing global regulatory strategies for biosimilar and pharmaceutical products. The role ensures successful product registrations and lifecycle management across major international markets, serving as the primary liaison with health authorities in Europe and the United States.

Responsibilities

• Define and implement global regulatory strategies for product launches, lifecycle management, and market expansion.
• Oversee the preparation and submission of Complex Technical Documents (CTDs), variations, renewals, and responses to health authorities.
• Serve as the main point of contact for international agencies, including the EMA and FDA.
• Partner with R&D, Quality, Manufacturing, Clinical, and Commercial teams to align regulatory efforts.
• Track changing regulatory landscapes and advise internal stakeholders on compliance and strategy.
• Review, approve, and manage regulatory documentation and labeling materials.
• Prepare the organization for audits and inspections to maintain regulatory compliance.
• Mentor junior staff and drive continuous improvement within the Regulatory Affairs function.
• 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 bodies in Europe, the US, and other international regions.
• 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.
• Excellent communication and stakeholder management skills.
• Fluency in English is mandatory.
• Ability to prioritize tasks effectively 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 work environment.
• Strategic position 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 de la Place du Cirque SA is a globally recognized healthcare organization committed to improving patient outcomes through high-quality medicines and innovative solutions. The company merges scientific excellence with regulatory expertise to deliver impactful therapies worldwide.

• Dedicated to patient-centric innovation and high-quality medicines.
• Dynamic Regulatory Affairs team environment.
• Focus on scientific excellence and regulatory expertise.