Regulatory Affairs Lead 80-100% (Ref. 2824) - Fribourg area

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

Job summary

AurigaVision AG, a Swiss biopharmaceutical company, is seeking an experienced Regulatory Affairs Lead in the Fribourg area to take regulatory responsibility for the Swiss product portfolio and oversee lifecycle management. You will work closely with Swiss authorities and internal teams to ensure compliance and timely submissions.

You will guide and support the Regulatory Affairs Specialist, coordinate regulatory activities across functions, and contribute to process improvements and SOP updates,

Qualifications

• Regulatory affairs experience within Swiss pharma (5+ years)
• Experience with regulatory submissions and product lifecycle management
• In-depth knowledge of Swiss regulatory requirements and Swissmedic
• Ability to translate complex regulations for stakeholders
• Fluency in English and German or French, third language a plus

Responsibilities

• Take regulatory responsibility for the Swiss product portfolio and lifecycle
• Monitor regulatory developments and translate into actions
• Plan and coordinate submission of dossiers, variations and renewals
• Maintain regulatory databases and update product information
• Manage interactions with Swissmedic and health authorities
• Provide regulatory guidance for cross-functional projects
• Support continuous improvement of regulatory processes and SOPs

Skills

Regulatory affairs

Swissmedic knowledge

Multilingual communication

Leadership

Education

University degree in Life Sciences, Pharmacy, Biomedical Sciences, Medicine

Job description

Our client is an internationally active biopharmaceutical company with a Swiss presence and a specialised portfolio across several therapeutic areas. To strengthen the Swiss team, we are looking for an experienced professional as

Regulatory Affairs Lead 80-100% (Ref. 2824)

Fribourg area

In this key position, you will take regulatory responsibility for the Swiss product portfolio and support products throughout their lifecycle. You will collaborate closely with various internal functions, external partners and Swiss health authorities while also providing guidance and support to a Regulatory Affairs Specialist.

Your main tasks

• Take responsibility for the regulatory strategy and its implementation across the Swiss product portfolio
• Monitor regulatory developments and translate changes into appropriate actions for existing and new products
• Plan, coordinate and ensure the 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 relevant health authorities and support regulatory inspections and audits
• Provide regulatory expertise for cross-functional projects and coordinate activities with key internal and external stakeholders
• Guide and support the Regulatory Affairs Specialist while contributing to the continuous improvement of regulatory processes, SOPs and work instructions

Your profile

• University degree in Life Sciences, Pharmacy, Biomedical Sciences, Medicine or a comparable scientific discipline
• At least 5 years of professional experience in Regulatory Affairs within the Swiss pharmaceutical industry
• Strong practical experience with regulatory submissions and pharmaceutical product lifecycle management
• In-depth knowledge of Swiss regulatory requirements and proven experience working with Swissmedic
• Ability to translate complex regulatory requirements into clear and pragmatic guidance for different stakeholders
• Fluency in English and either German or French, combined with a good working knowledge of the third language; fluency in all three languages is an advantage
• Independent, structured and solution-oriented working style combined with strong communication, organisational and leadership skills

Full discretion is guaranteed and we will gladly answer any additional questions.