Senior Regulatory Affairs Manager, India & South Asia

Job description

Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market Job Description Roles and Responsibilities Develop and execute regulatory strategies to support product registrations, market access, and lifecycle management across India and South Asia. Serve as the primary regulatory liaison to the Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), National Pharmaceutical Pricing Authority (NPPA), and other relevant health authorities. Lead regulatory interactions with health authorities to support product approvals, renewals, variations, labeling updates, safety matters, and post-approval commitments. Oversee the preparation, submission, tracking, and approval of regulatory applications through the CDSCO SUGAM Portal, ensuring compliance with applicable regulatory requirements and timelines. Drive timely resolution of regulatory queries, deficiency letters, and requests for additional information through effective engagement with health authorities and internal stakeholders. Monitor and interpret evolving regulatory requirements and policies, assess business impact, and provide strategic regulatory guidance. Partner with Global Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Affairs, Supply Chain, and Commercial teams to support compliance, product launches, and business continuity. Coordinate the collection, review, and maintenance of regulatory documentation within Veeva Vault, TrackWise Digital, and other applicable systems. Provide regulatory intelligence, training, and expert guidance to internal stakeholders on regulatory requirements and developments. Represent the company during regulatory inspections, authority meetings, industry forums, and stakeholder consultations as required. Required Qualifications This role requires advanced experience in the Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college (or a high school diploma with relevant experience). 8+ years experience in Regulatory Affairs Desired Characteristics Strong verbal and written communication skills, with the ability to effectively engage and influence stakeholders at all levels. Demonstrated analytical and problem-solving skills, with the ability to evaluate complex issues and develop practical solutions. Ability to plan, prioritize, and execute programs and initiatives, delivering high-quality outcomes in a dynamic environment. Well-developed project management skills, with the ability to manage multiple priorities and drive projects to completion. ​Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. We expect all employees to live and breathe our behaviors: act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. Additional Information Relocation Assistance Provided: No