sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate
Gilead Sciences
Zug, Switzerland
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10+ years regulatory affairs experience
Ma holder compliance management
Negotiation with local health authorities
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Gilead Sciences is seeking a Senior Manager / Associate Director of Regulatory Affairs for its Swiss Affiliate in Zug, Switzerland. The ideal candidate will have significant experience in regulatory affairs within the biopharma industry, focusing on compliance with local regulations and leading cross-functional teams to ensure successful product development and market authorization.
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Job Summary
The role serves as a core member of the Swiss Affiliate Regulatory Team, ensuring compliance with country-specific legislations and regulations linked to the Marketing Authorization.
Candidates will lead challenging regulatory submissions, manage interactions with local Health Authorities, and ensure compliant labeling for medicinal products.
Gilead seeks a strategic leader to drive the vision for the RA organization in the sub-region while fostering an inclusive environment where employees feel empowered.
Matching Summary
Match Score: 75
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Gilead Sciences is seeking a Senior Manager / Associate Director of Regulatory Affairs for its Swiss Affiliate in Zug, Switzerland. The ideal candidate will have significant experience in regulatory affairs within the biopharma industry, focusing on compliance with local regulations and leading cross-functional teams to ensure successful product development and market authorization.
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Skills & Requirements
Must-have
10+ years regulatory affairs experience
MA Holder compliance management
Negotiation with local health authorities
Cross-functional team leadership
Swiss pharmaceutical legislation knowledge
Nice-to-have
German mother tongue proficiency
Experience in Gilead therapeutic areas
Pharmacovigilance knowledge
Market access expertise
Mentoring and coaching skills
Key Requirements
BS/BA degree with 10+ years RA experience or advanced degree with 8+ years
Proven track record negotiating with regulatory authorities