Regulatory Affairs Associate Director, CMC

About this role

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.