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

AurigaVision AG; Freiburg; Presencial; CHF 140 000 - 190 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Regulatory Strategy

Lifecycle Management

Swissmedic liaison

Stakeholder leadership

Regulatory submissions

Formação académica

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

Descrição da oferta de emprego

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.

• 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.