Executive - Regulatory - Mumbai

Job description

• Percentage of registrations submitted as per the agreed filing plan. • Timely resolution and submission of regulatory queries. • Renewal submissions completed before product registration expiry. • Timely completion and approval of regulatory variations. • Accuracy and timeliness of payment coordination and reimbursement processes. • Effective tracking of dossier, registration, renewal, and variation status. • Effective coordination with internal teams, LTRs, and regulatory authorities. • Reduction in regulatory delays caused by pending documentation, payments, or stakeholder coordination. • Co-ordination and ensuring that the artworks for products which are under variation are completed and adhering to the required guidelines • Strong understanding of pharmaceutical regulatory affairs and dossier registration processes. • Knowledge of post-approval activities, including variations, renewals, and regulatory query management. • Strong coordination and stakeholder management skills. • Ability to manage multiple products, countries, timelines, and regulatory activities simultaneously. • Strong follow-up, documentation, tracking, and reporting skills. • Good understanding of payment approval and regulatory fee processes. • Attention to detail and ability to work within strict regulatory timelines. Key Stakeholders • Business Development and Marketing Teams • Regulatory Affairs Team at HO • Finance Team • Local Technical Representatives (LTRs) • Country-specific regulatory authorities and external partners Skills Required • Strong coordination and stakeholder management skills. • Excellent communication and follow-up skills • Candidate should be open to travel domestic and International