MANAGER/ SR. MANAGER - R.A

Position: Manager/ Sr. Manager - Regulatory Affairs Job Location: Corporate Office, Ahmedabad Experience required: 10 – 15 Years Qualification: ,M.Pharm/ B.Pharm/ M.Sc Job Summary: • Lead regulatory strategy, due diligence, and compliance activities for international markets. • Manage product registrations, renewals, variations, and regulatory submissions within timelines. • Review dossiers, tender documents, labeling, and compliance-related documentation. • Develop regulatory strategies supporting product development, commercialization, and lifecycle management. • Monitor global regulatory changes and provide strategic recommendations to stakeholders. • Collaborate with cross-functional teams to ensure successful product launches and market expansion. • Liaise with health authorities, distributors, partners, and consultants for regulatory matters. • Manage regulatory inspections, audits, GMP interactions, and compliance requirements. • Resolve regulatory queries, deficiencies, and compliance risks through stakeholder coordination. • Mentor regulatory team members and drive continuous improvement through regulatory intelligence and best practices. Required Skills: > Regulatory Strategy & Compliance Management > Global Product Registration & Lifecycle Management > Health Authority Interactions > Regulatory Intelligence & Risk Assessment > Cross-Functional Stakeholder Management > Technical Dossier Review & Submission Management > Good communication > Ownership