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 regula

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