Regulatory Affairs Lead (80-100%) - Fribourg

About the role

OM Pharma is looking for a Regulatory Affairs Lead (80-100%) to take charge of regulatory affairs for its Swiss portfolio, including partner products. The role combines strategic ownership with hands-on delivery: you will manage a Regulatory Specialist and work closely with cross-functional teams to ensure regulatory compliance throughout the product lifecycle. You will be based in Villars-sur-Glâne and report to the Head of Market Access & External Affairs, Swiss Affiliate.

Key responsibilities

• Lead regulatory strategy and operations for product development and lifecycle management across the Swiss portfolio, aligned with business objectives, timelines and budgets.
• Monitor regulatory developments and adapt strategies proactively to ensure compliance.
• Oversee the preparation, review and timely submission of regulatory dossiers, including variations and renewals.
• Maintain regulatory databases and coordinate product information and packaging updates.
• Lead or support interactions with Swissmedic and other health authorities, and represent the company during quality inspections and audits.
• Provide regulatory expertise to cross-functional projects and align activities with internal stakeholders.
• Develop or contribute to SOPs and work instructions, and drive continuous improvement of regulatory processes.
• Manage and support the Regulatory Specialist, setting objectives, coordinating daily priorities and improving team efficiency.

Required profile

• University degree in Life Sciences, Pharmacy, Biomedical Sciences, Medicine or an equivalent scientific discipline.
• At least 5 years' experience in Regulatory Affairs within the Swiss pharmaceutical industry, with hands-on expertise in regulatory submissions and lifecycle management, including variations and renewals.
• Proven experience working with Swissmedic and a solid understanding of Swiss regulatory requirements.
• Ability to turn complex regulatory requirements into clear, pragmatic guidance for internal stakeholders.
• Fluency in English and either French or German, with a good working knowledge of the third language; fluency in all three is preferred.

The ideal candidate is autonomous, well organised and pragmatic, able to balance competing priorities while maintaining quality and compliance, and acts as a supportive team leader who builds effective relationships and influences stakeholders constructively.