Job ID: REQ-10079740
Date: Jun 17, 2026
Location: Switzerland
Summary
#LI-Hybrid (12 days per month on-site)
Office Location: Basel, Switzerland
Novartis is seeking a Manager/Senior Manager to oversee regulatory activities related to Chemistry, Manufacturing and Controls (CMC). This role includes the preparation and publication of CMC regulatory documentation for Health Authority submissions, as well as engaging with Health Authorities on CMC-related inquiries to support both new product launches and post-marketing activities.
About the Role
Major Accountabilities
- Formulate, lead, and drive global CMC regulatory strategy with a focus on innovation, balancing business benefits with regulatory compliance.
- Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify required documentation and address any content, quality, and/or timelines issues for global submissions, negotiating the delivery of approved technical source documents in accordance with project timelines.
- Author and/or review high-quality CMC documentation for Health Authority submission, ensuring alignment with agreed CMC global regulatory strategies, current regulatory trends, and guidelines while meeting technical congruency and regulatory compliance.
- Proactively communicate CMC regulatory strategies, risks, and key issues throughout the life cycle to project teams and other stakeholders, representing the department in cross-functional project teams.
- Lead, prepare, and communicate CMC risk management assessments and lessons learned on major submissions.
- Initiate and lead interactions and negotiations with Health Authorities.
Essential Requirements
- Science degree (e.g., Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent.
- Minimum 5 years of regulatory CMC experience and/or pharmaceutical industry experience.
- Demonstrated knowledge and experience in regulatory submission and approval processes, with the ability to address complex CMC regulatory issues and requirements.
- Proven ability to critically evaluate data from a broad range of scientific disciplines.
Commitment to Diversity and Inclusion
Novartis is dedicated to cultivating an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
We are committed to providing reasonable accommodations to individuals with medical conditions or disabilities. If you require assistance during the recruitment process or need more detailed information about the essential functions of a position, please send an email to inclusion.switzerland@novartis.com, specifying your request and contact information. Please include the job requisition number in your message.
Why Novartis
Helping people with diseases and their families requires more than innovative science; it takes a community of passionate individuals. At Novartis, we collaborate, support, and inspire each other to achieve breakthroughs that transform patients' lives. Are you ready to create a brighter future together?
Learn more about our vision: Novartis People and Culture
Benefits and Rewards
Discover all the ways we can help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Additional Information
- Division: Development
- Business Unit: Development
- Location: Switzerland
- Site: Basel (City)
- Company / Legal Entity: C028 (FCRS = CH028) Novartis Pharma AG
- Functional Area: Research & Development
- Job Type: Full time
- Employment Type: Regular
- Shift Work: No
Application
Apply online using the form below. Please note that only applications matching the job profile will be considered.