• 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.

• Solid 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.

Advantages

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

• Prospect to work cross-functionally with Regulatory Affai

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