Global Regulatory Leader - Biosimilars

• Full Time
  
  • Switzerland (Remote)
  • Posted 21 hours ago
  • Negotiable CHF / Year

Global Regulatory Leader - Biosimilars

About Our Client

Our client is a globally recognized healthcare organization dedicated to improving patient outcomes through high-quality medicines and innovative healthcare solutions. With a strong international footprint and a growing focus on biosimilars, the company combines scientific excellence, regulatory expertise, and patient-centric innovation to deliver impactful therapies worldwide.

Their Swiss-based operations close to Nyon play a key role in global regulatory strategy and product lifecycle management, supporting complex international submissions across major markets including Europe and the United States.

The Opportunity

We are seeking an experienced and strategic Global Regulatory Leader (GRL) to join a dynamic Regulatory Affairs team in Switzerland. In this role, you will take ownership of global regulatory strategies and lead complex submissions for biosimilar and pharmaceutical products across international markets.

This is an excellent opportunity for a regulatory affairs professional who enjoys working in a highly collaborative, science-driven environment and wants to influence global product development and market access strategies.

Key Responsibilities

• Lead and execute global regulatory strategies for product registrations, lifecycle management activities, and market expansion initiatives
• Manage and coordinate regulatory submissions including CTDs, variations, renewals, and responses to health authorities
• Act as the primary regulatory contact for international regulatory agencies including EMA, FDA, and other global authorities
• Collaborate closely with cross-functional teams across R&D, Quality, Manufacturing, Clinical, and Commercial functions
• Monitor evolving regulatory requirements and provide strategic guidance to internal stakeholders
• Prepare, review, and approve regulatory documentation and labeling materials
• Support audit and inspection readiness activities and contribute to regulatory compliance initiatives
• Mentor junior team members and contribute to continuous process improvement within Regulatory Affairs
• Represent Regulatory Affairs in global project teams and external regulatory discussions

What Our Client Is Looking For

• Advanced degree in Pharmacy, Life Sciences, or a related scientific discipline
• Extensive experience in Regulatory Affairs within the pharmaceutical or biotech industry
• Strong expertise in biosimilars and global regulatory submissions
• Proven experience with regulatory authorities across Europe, the US, and international markets
• In-depth knowledge of ICH, EMA, FDA, and WHO guidelines
• Strong understanding of drug development, clinical development processes, and quality systems
• Demonstrated project leadership and cross-functional collaboration skills
• Excellent communication and stakeholder management abilities
• Fluent English skills are required; French or German would be advantageous
• Ability to manage multiple priorities in a fast-paced international environment

Why Join Our Client?

• Opportunity to work on innovative biosimilar and pharmaceutical products with global impact
• International and collaborative working environment
• Strategic role with strong 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

If you are passionate about global regulatory affairs and would like to contribute to the development of accessible, high-quality therapies worldwide, we would be pleased to hear from you.

Contact me for more details and I will give you a call to discuss the role in details:

• email address: [email protected]

For a confidential discussion about this role, or to apply, then send your CV to [email protected].