Regulatory Affairs Lead, Swiss Lifecycle & Strategy

OM Pharma Ltd.

Glanewiler

On-site

CHF 140,000 - 190,000

Full time

2 days ago

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Job summary

OM Pharma Ltd. is seeking a Regulatory Affairs Lead to drive Swiss regulatory strategy and lifecycle management for its Swiss portfolio.

Based in Villars-sur-Glâne, you will lead a Regulatory Specialist and collaborate with cross-functional teams to ensure compliance across development and product lifecycle. The role demands a university life sciences degree, 5+ years in Regulatory Affairs, and fluency in English with French or German.

Qualifications

University degree in life sciences, pharmacy or related field.
At least 5 years’ experience in Regulatory Affairs in the Swiss pharmaceutical industry, with hands-on expertise in submissions and lifecycle management.
Proven experience with Swissmedic and a solid understanding of Swiss regulatory requirements.
Ability to translate complex regulatory requirements into clear, pragmatic guidance for internal stakeholders.
Fluency in English and French or German, with good working knowledge of the third language; fluency in all three is preferred.

Responsibilities

Lead regulatory strategy and operations for product development and lifecycle management across the Swiss portfolio, aligned with objectives, timelines and budgets.
Monitor regulatory developments and adapt strategies to ensure ongoing compliance.
Oversee preparation, review and timely submission of regulatory dossiers, variations and renewals.
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 inspections and audits.
Provide regulatory expertise to cross-functional projects and align activities with stakeholders.
Develop or contribute to SOPs and drive continuous improvement of regulatory processes and systems.
Manage and support the Regulatory Specialist, setting objectives and prioritising daily work.