Senior Regulatory Affairs Manager, India & South Asia

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

Roles and Responsibilities

- Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.

- Maintain effective engagement with local health authorities and regulatory agencies across India and South Asia. In India:

- Serve as the primary regulatory liaison to CDSCO, DCGI, NPPA, and other relevant health authorities.

- Drive the preparation, submission, tracking, and approval of regulatory applications through the CDSCO SUGAM Portal, ensuring compliance with applicable requirements and timelines.

- Oversee Regulatory Affairs teams supporting distributor markets in South Asia, including governance, compliance oversight, capability development, and conducting Regulatory Affairs Distributor Qualification Audits.

- Lead regulatory interactions with health authorities to support product approvals, renewals, variations, labelling updates, safety matters, post-approval commitments, and resolution of regulatory queries and deficiency letters.

- Provide regulatory intelligence expertise through the interpretation of evolving regulatory requirements, assessment of business impact, and development of strategic recommendations for internal stakeholders.

- 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 preparation, review, and maintenance of regulatory documentation and records within Veeva Vault, TrackWise Digital, and other applicable systems.

- Represent the company during regulatory inspections, authority meetings, industry forums, and stakeholder consultations.