Executive - Regulatory - Mumbai

• 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