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

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

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

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

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

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

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

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

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

10.



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

Requirements

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

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

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

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

Benefits

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

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

3. Growth opportunities opportunities in Regulatory Operations, Regulatory Affairs, and Regulatory Project Management.

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