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
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.
Serve as a subject matter expert and mentor, leading cross-functional projects of varying complexity, influencing stakeholders, building consensus, and managing sensitive issues and competing priorities.
Operate with a high degree of autonomy, applying sound judgment and regulatory expertise to address complex challenges, drive compliance, and ensure the consistent implementation of global procedures and best practices.
