Farmak International is an international pharmaceutical company focused on the development and global commercialization of generic and complex medicines, with in-house manufacturing capabilities. Operating through a network of international offices and three manufacturing sites in Europe, we work across diverse regions and regulated environments, with a primary focus on Europe, the UK, the Middle East and Africa (MEA), Southeast Asia (SEA), and countries across the Americas. Our medicines are supplied to healthcare systems in more than 60 countries worldwide, addressing a wide range of local market needs. We provide end-to-end B2B solutions across the product lifecycle — from research and formulation development to manufacturing, licensing, and market entry — building long-term partnerships aligned with our mission of driving quality medicines worldwide. Learn more at www.farmak.ch.
About the Role
We are looking for a Regulatory Affairs Lead to join our team in Baar (Zug-Switzerland). The mission of this role is to own and drive Switzerland Local Regulatory Affairs for the MAH, ensuring end-to-end compliance across Swissmedic and FOPH/BAG requirements—from dossier strategy, Module 1 maintenance and eCTD submissions through lifecycle execution (variations, renewals, safety-driven label updates, PSUR coordination, and authority query management, including controlled substances where applicable). Enable timely market access and sustainable commercialization by delivering SL pricing/reimbursement submissions and managing pricing reviews, while providing Swiss regulatory intelligence, maintaining inspection readiness and robust local governance, and coordinating seamlessly with Global RA/RegOps, PV, QA, Supply Chain, Commercial, and external partners to secure continuous, compliant supply in Switzerland.
Marketing Authorization & Lifecycle Management (Swissmedic)
Lead preparation, compilation, and submission of MAAs to Swissmedic (national procedures, incl. applications based on reference country authorizations where applicable).
Prepare, maintain, and ensure compliance of Switzerland-specific Module 1 documentation.
Perform eCTD publishing, validation, and submission activities for Switzerland using approved publishing tools and internal SOPs.
Own product lifecycle management for Switzerland: variations, renewals, PSUR coordination/submission (where applicable), and implementation of authority decisions.
Coordinate Swissmedic queries/deficiency responses and ensure timely, high-quality resolution and internal alignment.
Maintain and update Swiss local product information (SmPC, PIL, labeling/packaging components) and manage label change implementation with relevant stakeholders.
Manage regulatory aspects for controlled substances, including narcotics authorizations and related compliance obligations (where applicable).
Ensure submission tracking, archival, and dossier completeness for Switzerland, including maintenance of global and local regulatory trackers and repositories.
Prepare and submit pricing applications to FOPH/BAG for inclusion in the Spezialitätenliste (SL).
Monitor SL/pricing reviews and coordinate responses to reassessments, data requests, and timelines.
Partner with Market Access/Commercial to shape and execute pricing strategy and evidence packages aligned with Swiss requirements.
Swiss Regulatory Strategy, Intelligence & Compliance
Monitor Swiss regulatory developments (Swissmedic/FOPH/BAG guidance, legislative changes) and assess impact on current and pipeline products.
Provide Switzerland-specific regulatory input to global strategy and submission planning, including sequencing, risk identification, and mitigation plans.
Ensure ongoing compliance with Swissmedic requirements and maintain inspection readiness for MAH obligations (procedures, documentation, tracking, audit support).
Maintain/own local regulatory SOPs/WIs as needed and drive continuous improvement of Switzerland regulatory processes with Global RA/RegOps.
Stakeholder Management & Cross-functional Collaboration
Serve as the primary local contact for Swissmedic and other relevant Swiss authorities; manage professional communication and meeting preparation/follow-up.
Collaborate with Global RA and Regulatory Operations on dossier strategy, authoring needs, publishing readiness, and submission scheduling.
Liaise with QA and Supply Chain on regulatory topics affecting Switzerland (e.g., changes impacting Swiss packs, manufacturing/site changes, import/release considerations, and supply continuity communications where applicable).
Support Commercial/Market Access with compliant use of approved product information and Switzerland regulatory considerations for materials and activities (as applicable).
Coordinate and oversee external consultants/service providers for Swiss regulatory and pricing activities, ensuring quality, timelines, and budget adherence.
Local Pharmacovigilance & Safety Oversight
Serve as the RP-PV for Switzerland and Liechtenstein, managing all local safety issues, quality complaints, and adverse event reporting in alignment with Swiss legislation.
Coordinate with the EU-QPPV for clinical evaluations, screen local medical literature, and maintain Safety Data Exchange Agreements (SDEAs) and PV standard operating procedures.
Ensure readiness for and lead participation in self-inspections and official PV inspections by Swissmedic or third parties.
Qualifications
Required: University degree in Pharmacy, Life Sciences, Chemistry, or a related field (MSc or equivalent preferred)
Professional Experience
Minimum 5 years of experience in regulatory affairs within the pharmaceutical industry
Demonstrated experience with Swissmedic registration procedures and Swiss regulatory requirements
Experience with generic medicinal products preferred
Proven track record in preparing and managing marketing authorization applications in Switzerland
eCTD compilation and publishing
Swiss pricing and reimbursement procedures (BAG/FOPH)
Pharmacovigilance regulations and local PV activities
Regulatory Information Management Systems
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