Regulatory Affairs CMC Manager (Cell & Gene Therapies)

Major accountabilities:

• Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance.
• Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
• Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
• Prepare and communicate CMC risk management assessments and lessons learned on major submissions.
• Initiate and lead Health Authority interactions and negotiations.

Minimum requirements:

• Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent
• At least 2 years’ experience in regulatory CMC experience and/or pharmaceutical industry experience; working knowledge in regulatory submissions desirable.
• Demonstrated working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
• Knowledge/experience of regulations, guidelines and product life cycle maintenance.
• Ability to critically evaluate data from a broad range of scientific disciplines.

Commitment to Diversity and Inclusion/EEO

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 E-Mail schreiben and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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