Summary Responsible for regulatory activities specifically related to chemistry manufacturing and control CMC Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities In addition interact with HA s on REG CMC questions to support new product or post marketed launches About the Role Key responsibilities Formulate and lead global CMC regulatory strategy with a focus on innovation maximizing the business benefit balanced with regulatory compliance -Lead and implement all 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 Prepare and communicate CMC Risk Management Assessments contingency plans and lessons learned on major submissions and escalate with management as appropriate Initiate and lead Health Authority interactions and negotiations as appropriate setting objectives preparing briefing books coordinating and planning rehearsals and risk mitigation plans Reporting of technical complaints adverse events special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples where applicable Essential requirements Minimum of 8 years in Regulatory affairs-CMC Proven track record of HA negotiations Ability to develop and communicate strategic vision Ability to work in cross-functional environment Proven expertise in project management Highly committed and team oriented Proven strong matrix leadership skills Proven track record of early recognition of potential regulatory issues complex situations sound risk assessment and overcoming hurdles Strong team player Proven track record of successful risk assessment Organizational awareness Ability to travel and represent the organization Postgraduate in Pharmacy or Chemistry Biochemistry Biotechnology or equivalent Desirable Experience in Regulatory affairs-CMC authoring Commitment to Diversity and Inclusion 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 individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to diversityandincl india 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 creative 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 Join our Novartis Network Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up https talentnetwork novartis com network Benefits and Rewards Read our handbook to learn about all the ways we ll help you thrive personally and professionally https www novartis com careers benefits-rewards Division Development Business Unit Development Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Functional Area Research Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to email protected and let us know the nature of your request and your contact information Please include the job requisition number in your message Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve