Regulatory Affairs Associate Director, CMC

Description du poste

Job ID REQ-10078161 May 15, 2026 Switzerland ### Summary ### \#LI-Hybrid Location: Basel, Switzerland We are looking for a Regulatory Affairs Associate Director, CMC to contribute to the development and delivery of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies across a portfolio of products. In this role, you will support regulatory activities across development and lifecycle stages, ensuring high-quality submission content and alignment with global regulatory requirements. Working closely with cross-functional partners, you will help enable timely approvals and maintain compliant, consistent product information across markets. ### About the Role ### **Major Accountabilities** * Contribute to the development and implementation of global CMC regulatory strategies for assigned projects and products. * Plan, coordinate, and support CMC submission activities, including authoring, review, and submission of documentation. * Identify documentation requirements and manage alignment on content, quality, and timelines across stakeholders. * Author and review high-quality CMC regulatory documentation, ensuring compliance with applicable guidelines and standards. * Communicate regulatory considerations, risks, and updates to cross-functional project teams and stakeholders. * Contribute to and support Health Authority interactions, including preparation of briefing materials and responses. * Collaborate across functions to support consistent delivery and alignment on regulatory activities. * Contribute to continuous improvement initiatives and support knowledge sharing within the regulatory community. **Essential Requirements** * Fluency in English (written and spoken). * Degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent experience. * Demonstrated capability in CMC Regulatory Affairs, including regulatory submission and approval processes. * Strong understanding of CMC regulatory requirements, with the ability to navigate complex regulatory topics and contribute to regulatory strategy. * Ability to evaluate scientific data across multiple disciplines and translate insights into regulatory decision-making and documentation. * Working knowledge of pharmaceutical development, manufacturing, or related scientific areas. * Ability to collaborate effectively and influence within cross-functional, global matrix teams while managing multiple priorities. * Strong planning, organisational, and interpersonal skills, with a focus on quality, delivery, and continuous improvement. **Commitment to Diversity and Inclusion / EEO paragraph**  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 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.  **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients- lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture **Benefits and Rewards:** Learn about all the ways we-ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) 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 Play Play 00:00 Play Seek 10 seconds backwards Seek 10 seconds forward 00:00 / 01:54 Mute Click to volume controlUse the arrows to control the volume Settings Turn on Picture in picture Show Full screen Research & Development Development Switzerland Job ID REQ-10078161 ### Regulatory Affairs Associate Director, CMC ### Apply to Job (link is external)