Manager Regulatory Affairs - Mumbai
Core
Lead and execute local regulatory activities to ensure product registrations, compliance, and patient access to innovative healthcare solutions.
Role type
Manager, Regulatory Affairs
Builds
Product registrations, marketing authorizations, and regulatory dossiers for pharmaceutical products
Domain
Biopharmaceuticals / Healthcare
Required skills
Regulatory dossier preparation, product registration maintenance, health authority interaction, regulatory database management, risk management, budget planning, cross-functional collaboration, D&C Act knowledge, business acumen
Preferred skills
People management, critical thinking, problem solving, negotiation, agility
Technologies
Regulatory databases, filing systems
Responsibilities
Execute regulatory activities aligned with business priorities, prepare and submit regulatory dossiers, maintain product registrations and marketing authorizations, monitor regulatory environment changes, build relationships with health authorities and vendors, partner with cross-functional teams, support product launches and brand growth, manage regulatory activity costs, contribute to risk management and continuous improvement, mentor team members
Seniority
Manager, people leadership