- 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.




- 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.
- 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