Regulatory Affairs Lead – Swiss Portfolio & Lifecycle

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

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.