- Plan and maintain regulatory project timelines, submission trackers, and country-specific schedules across Central American markets.

- Monitor end-to-end dossier readiness, including documentation, QC, formulation, manufacturing, analytical testing, review, and finalization.

- Review technical documentation, product specifications, analytical methods, and quality documents for regulatory compliance.

- Coordinate analytical testing of regulatory samples with internal and external laboratories and monitor testing timelines.

- Review analytical data, QC reports, laboratory results, and batch manufacturing records for accuracy and compliance.

- Coordinate with QC, R&D;, Manufacturing, and external laboratories to resolve technical and documentation discrepancies.

- Track dossier compilation, review, finalization, submission, and regulatory query responses against defined timelines.

- Identify project delays, bottlenecks, dependencies, and risks and coordinate corrective actions to ensure timely completion.

- Ensure regulatory activities comply with RTCA requirements, country-specific regulations, SOPs, and defined workflows.





- Maintain regulatory dashboards, project documentation, and status reports and provide structured updates on progress, risks, and pending activities.

Requirements

- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline (mandatory).

- 2–4 years of experience in Pharmaceutical Regulatory Affairs, Regulatory Operations, or regulatory project management.

- Strong experience in regulatory timelines, trackers, dossier coordination, technical documentation, and analytical data review.

- Working knowledge of RTCA regulations and Central American regulatory processes with strong coordination and project execution skills.

Benefits

- High-ownership role with exposure to Central American regulatory markets and RTCA requirements.

- Chance to work cross-functionally with Regulatory Affairs, QC, R&D;, Manufacturing, and external laboratories.

- Career growth opportunities in Regulatory Operations, Regulatory Affairs, and Regulatory Project Management.

📌 Senior Executive - Regulatory Operation (Dehradun)
🏢 Rhydburg
📍 Dehradun