Regulatory Affairs Manager/Senior Manager, CMC
Hybrid · Basel, Basel-City, Switzerland
Job Summary
Lead global CMC regulatory strategy and submission activities for Health Authority submissions, author/review high-quality CMC documentation, and manage cross-functional project teams to ensure regulatory compliance and timely delivery. Drive global CMC submissions planning, coordination, and e-publishing; identify and resolve content and timeline issues; initiate Health Authority interactions and negotiations; communicate regulatory risks and strategies to project teams; and support both new product launches and post-marketing activities. Requires a science degree and minimum 5 years of regulatory CMC experience, with demonstrated HA submission knowledge and ability to handle complex regulatory issues.
Required Qualifications
- Science degree or equivalent (Chemistry/Pharmacy/Biology)
- Minimum 5 years of regulatory CMC experience
- Demonstrated knowledge/experience in regulatory submission and approval processes
- Ability to critically evaluate data from a broad range of scientific disciplines
- Proven experience in Health Authority interactions and negotiations
- Experience with global CMC submission activities and e-publishing requirements
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