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