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
Robust understanding of pharmaceutical regulatory affairs and dossier registration processes.
Knowledge of post-approval activities, including variations, renewals, and regulatory query management.




Robust coordination and stakeholder management skills.
Ability to manage multiple products, countries, timelines, and regulatory activities simultaneously.
Solid follow-up, documentation, tracking, and reporting skills.
Positive 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

📌 Executive Regulatory Mumbai
🏢 Hetero
📍 Mumbai