Regulatory Affairs Lead (80 - 100%) - Fribourg

OM Pharma Ltd.; Freiburg; Hybrid; CHF 140,000 - 190,000; Full time

Job summary

OM Pharma Ltd. in Fribourg is seeking a Regulatory Affairs Lead (80–100%) to drive regulatory strategy for the Swiss portfolio, oversee submissions, and lead cross-functional collaboration with Swissmedic and health authorities. You will mentor the Regulatory Specialist and ensure lifecycle management is aligned with business goals.

The role emphasizes strategic oversight, hands-on dossier preparation, and strong internal stakeholder communication in a fast-paced regulatory environment.

Qualifications

• 5+ years in Regulatory Affairs within the Swiss pharmaceutical industry.
• Hands-on expertise in regulatory submissions and lifecycle management (variations/renewals).
• Fluency in English and French or German; fluent in all three preferred.

Responsibilities

• Lead regulatory strategy and operations for Swiss portfolio and lifecycle management.
• Monitor regulatory developments and adapt strategies for compliance.
• Prepare and submit regulatory dossiers, variations, and renewals.
• Maintain regulatory databases and coordinate product information and packaging updates.
• Interact with Swissmedic and health authorities; represent the company during inspections.
• Provide regulatory guidance to cross-functional projects and align with stakeholders.
• Develop or contribute to SOPs and drive improvements in processes and systems.
• Manage and coach the Regulatory Specialist and improve team delivery.

Skills

Regulatory affairs

Regulatory submissions

Swissmedic

Leadership

Stakeholder management

Education

University degree in Life Sciences/Pharma

Tools

Regulatory databases

Job description

Regulatory Affairs Lead (80 - 100%) - Fribourg

Location: Villars-sur-Glâne, Fribourg, CH

Division: Regulatory Affairs

Job Type: Permanent role

Take the lead in regulatory affairs for OM Pharma’s Swiss portfolio, including partner products. Combining 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. Based in Villars-sur-Glâne, you will report to the Head of Market Access & External Affairs, Swiss Affiliate.

Your key responsibilities are as follows:

• 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 proactively adapt strategies to ensure compliance throughout the product lifecycle
• Oversee the preparation, review and timely submission of regulatory dossiers, including variations and renewals, as applicable
• 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 key internal stakeholders
• Develop or contribute to SOPs and work instructions, driving continuous improvement of regulatory processes and systems
• Manage and support the Regulatory Specialist, setting objectives, coordinating daily priorities and improving team efficiency and project delivery

What you bring:

• A 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
• The ability to translate complex regulatory requirements into clear, pragmatic guidance for internal stakeholders
• Strong language skills: fluency in English and either French or German, with a good working knowledge of the third language; fluency in all three is preferred

You combine sound regulatory judgement with a pragmatic, hands-on and business-oriented approach. Autonomous and well-organised, you balance competing priorities without compromising quality or compliance. You build effective relationships, communicate clearly and influence stakeholders constructively. As a supportive team leader, you provide clear direction and foster collaboration and continuous improvement.

About Us

OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.