RA CMC Manager/Senior Manager
RA CMC Manager/Senior Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description Summary
#LI-HybridLocation: Basel Switzerland (12 days per month on site)
Are you experienced in regulatory activities related CMC In this role youll be responsible for preparing and publishing high-quality CMC documentation for submission to Health Authorities while also engaging directly with regulatory agencies to address CMC-related queries. Your expertise will play a key role in supporting both new product registrations and post-marketing launches.
Job Description
Key responsibilities:
Formulateand lead global CMC regulatory strategy with a focus on innovation maximizing business benefit while ensuring regulatory compliance.
Leadand implement all global CMC submission activitiesincluding planning authoring reviewing coordination and submissionfor assigned projects and products.
Identifyrequired documentation and proactively address content quality or timeline issues for global submissions negotiating timely delivery of approved technical source documents.
Authorand/or review high-quality CMC documentation for Health Authority submissions applying global regulatory strategies and staying aligned with current trends and guidelines.
Ensuretechnical consistency and regulatory compliance meeting agreed timelines and e-publishing requirements.
Prepareand communicate CMC Risk Management Assessments contingency plans and lessons learned for major submissions escalating to management when necessary.
Initiateand lead Health Authority interactions and negotiations including setting objectives preparing briefing books coordinating rehearsals and developing risk mitigation plans.
Reporttechnical complaints adverse events or special case scenarios related to Novartis products within 24 hours of receipt.
Distributemarketing samples where applicable.
Essential requirements:
Education Minimum: Science degree (e.g. Chemistry Pharmacy Biochemistry Molecular Biology Biotechnology Biology) or equivalent; advanced degree desired.
Minimum 5 years of regulatory CMC experience and/or pharmaceutical industry experience.
Demonstrated knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
Proven ability to critically evaluate data from a broad range of scientific disciplines.
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Change Control Cross-Functional Teams Documentation Management Negotiation Skills Regulatory Compliance Risk Assessment Risk Management Waterfall ModelRequired Experience:
Senior Manager
Employment Type
Full-Time
