RA CMC Manager/Senior Manager

Band

Level 4

 

Job Description Summary

#LI-Hybrid
Location: Basel, Switzerland (12 days per month on site)

Are you experienced in regulatory activities related CMC? In this role, you’ll 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:

• Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing business benefit while ensuring regulatory compliance.

• Lead and implement all global CMC submission activities—including planning, authoring, reviewing, coordination, and submission—for assigned projects and products.

• Identify required documentation and proactively address content, quality, or timeline issues for global submissions, negotiating timely delivery of approved technical source documents.

• Author and/or review high-quality CMC documentation for Health Authority submissions, applying global regulatory strategies and staying aligned with current trends and guidelines.

• Ensure technical consistency and regulatory compliance, meeting agreed timelines and e-publishing requirements.

• Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned for major submissions, escalating to management when necessary.

• Initiate and lead Health Authority interactions and negotiations, including setting objectives, preparing briefing books, coordinating rehearsals, and developing risk mitigation plans.

• Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.

• Distribute marketing 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 team’s 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 inclusion.switzerland@novartis.com 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 Model