Regulatory Affairs CMC Manager

Job Description: As a Regulatory Affairs - CMC Specialist at Novartis, you will be responsible for activities related to chemistry, manufacturing, and control (CMC) for regulatory submissions to Health Authorities. Your role will involve formulating and leading global CMC regulatory strategy, authoring high-quality CMC documentation, and interacting with Health Authorities to support product launches. Key Responsibilities: - Lead global CMC regulatory strategy, focusing on innovation while ensuring regulatory compliance - Manage all global CMC submission activities for assigned projects/products - Identify required documentation for global submissions and negotiate delivery of approved technical documents - Author and review CMC documentation for Health Authority submission - Ensure technical congruency, regulatory compliance, and timely submission - Prepare CMC Risk Management Assessments, contingency plans, and escalate issues as needed - Initiate and lead Health Authority interactions and negotiations - Report technical complaints, adverse events, and distribute marketing samples as required Qualifications Required: - Minimum of 8+ years in Regulatory Affairs-CMC - Proven track record in HA negotiations and strategic vision development - Ability to work in a cross-functional environment and strong project management skills - Highly committed, team-oriented, with strong matrix leadership - Ability to recognize regulatory issues, conduct risk assessments, and overcome hurdles - Postgraduate in Pharmacy, Chemistry, Biochemistry, Biotechnology or equivalent - Ability to travel and represent the organization Additional Details: Novartis is committed to diversity and inclusion, creating an outstanding work environment and diverse teams. The company provides reasonable accommodation to individuals with disabilities. If you require accommodation during the recruitment process, please contact diversityandincl.india@novartis.com. Why Novartis: Novartis is dedicated to helping patients and communities through innovative science and a community of passionate individuals. Join Novartis to collaborate, support, and inspire breakthroughs that change patients" lives. Learn more at https://www.novartis.com/about/strategy/people-and-culture. Join Our Novartis Network: If this role is not suitable for you, sign up for Novartis" talent community to stay connected and learn about career opportunities. Visit https://talentnetwork.novartis.com/network. Benefits and Rewards: Explore the handbook to discover how Novartis helps employees thrive personally and professionally. Visit https://www.novartis.com/careers/benefits-rewards.,