Regulatory Affairs Lead – Swiss Portfolio & Lifecycle

AurigaVision AG; Freiburg; On-site; CHF 140,000 - 190,000; Full time

Job summary

AurigaVision AG is seeking an experienced Regulatory Affairs Lead to manage the Swiss product portfolio. In Fribourg, you will lead regulatory strategy, coordinate dossier submissions, and liaise with Swiss health authorities.

You will mentor a Regulatory Affairs Specialist and drive process improvements. The role requires a minimum of five years in Regulatory Affairs, strong Swiss regulatory knowledge, and fluency in English plus German or French.

Qualifications

• Minimum 5 years in Regulatory Affairs within the Swiss pharmaceutical industry.
• Experience with Swissmedic submissions.
• Strong communication and leadership skills.
• Ability to translate complex regulatory requirements for diverse stakeholders.

Responsibilities

• Take responsibility for the regulatory strategy and its implementation across the Swiss product portfolio.
• Monitor regulatory developments and translate changes into actions for existing and new products.
• Plan, coordinate and ensure timely submission of regulatory dossiers, including variations and renewals.
• Maintain regulatory databases and coordinate updates to product information and packaging materials.
• Manage interactions with Swissmedic and other health authorities; support inspections and audits.
• Provide regulatory expertise for cross-functional projects; coordinate activities with internal and external stakeholders.
• Guide and support the Regulatory Affairs Specialist while contributing to continuous improvement of regulatory processes and SOPs.

Skills

Regulatory Strategy

Lifecycle Management

Swissmedic liaison

Stakeholder leadership

Regulatory submissions

Education

University degree in Life Sciences, Pharmacy, Biomedical Sciences, Medicine or a comparable scientific discipline

Job description

AurigaVision AG is seeking an experienced Regulatory Affairs Lead to manage the Swiss product portfolio. In Fribourg, you will lead regulatory strategy, coordinate dossier submissions, and liaise with Swiss health authorities.

You will mentor a Regulatory Affairs Specialist and drive process improvements. The role requires a minimum of five years in Regulatory Affairs, strong Swiss regulatory knowledge, and fluency in English plus German or French.