Regulatory Affairs CMC Manager

As a Regulatory Affairs-CMC Specialist at Novartis, your role will involve handling regulatory activities related to chemistry, manufacturing, and control (CMC). You will be responsible for preparing and publishing REG CMC documentation for submissions to Health Authorities. Additionally, you will interact with Health Authorities on REG CMC questions to support new product launches and post-market activities. Key Responsibilities: - Formulate and lead global CMC regulatory strategy, focusing on innovation while ensuring regulatory compliance. - Lead and oversee all global CMC submission activities for assigned projects/products. - Identify required documentation for global submissions, address content, quality, and timeline issues, and ensure timely delivery of approved technical documents. - Author and review high-quality CMC documentation for Health Authority submission following global regulatory strategies and guidelines. - Ensure technical congruency, regulatory compliance, and meet e-publishing requirements within agreed timelines. - Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions. - Initiate and lead interactions and negotiations with Health Authorities, preparing briefing materials and risk mitigation plans. - Report technical complaints, adverse events, and special case scenarios related to Novartis products promptly. - Distribute marketing samples where applicable. Qualifications Required: - Minimum of 8+ years of experience in Regulatory Affairs-CMC. - Proven track record in HA negotiations and the ability to develop and communicate strategic visions. - Expertise in project management and working in cross-functional environments. - Strong matrix leadership skills and commitment to teamwork. - Early recognition of regulatory issues, sound risk assessment, and problem-solving abilities. - Postgraduate degree in Pharmacy, Chemistry, Biochemistry, Biotechnology, or equivalent. Desirable Qualifications: - Experience in Regulatory Affairs-CMC authoring. Novartis is committed to fostering diversity and inclusion in the workplace, aiming to create an inclusive work environment and diverse teams that represent the patients and communities they serve. If you require any accommodations due to a medical condition or disability during the recruitment process or while performing job functions, please reach out to diversityandincl.india@novartis.com with your request and contact information. Novartis values collaboration, support, and inspiration among its employees to achieve breakthroughs that positively impact patients" lives. Join the Novartis community to contribute to a brighter future together and explore career opportunities within the network. For more information on benefits and rewards offered by Novartis, please refer to the handbook: https://www.novartis.com/careers/benefits-rewards.,