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 a

📌 Senior Regulatory Affairs Manager, India (Gurugram)
🏢 GE Healthcare
📍 Gurugram