Senior Regulatory Affairs Manager, India & South Asia
Core
Develop and execute regulatory strategies for pharmaceutical product launches, premarket submissions, and post-market compliance across India and South Asia.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory applications and approvals for pharmaceutical products
Domain
Healthcare / Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, product registration, lifecycle management, compliance, stakeholder engagement, regulatory intelligence, project management, cross-functional collaboration, documentation management, inspection readiness, mentorship
Preferred skills
Advanced expertise in pharmaceutical regulatory affairs, ability to influence stakeholders, analytical problem-solving, program execution
Technologies
CDSCO SUGAM Portal, Veeva Vault, TrackWise Digital
Responsibilities
Serve as primary regulatory liaison to CDSCO, DCGI, NPPA; drive preparation and approval of regulatory applications; oversee distributor market governance and qualification audits; lead interactions with health authorities for approvals and renewals; provide regulatory intelligence and strategic recommendations; coordinate regulatory documentation in Veeva and TrackWise; represent the company in inspections and forums; mentor cross-functional teams
Seniority
Senior, hands-on IC with leadership responsibilities
