Prepare, compile, and review registration dossiers (CTD/eCTD formats) for product submissions to ROW/ CIS markets in compliance with local regulatory requirements.
Coordinate with cross-functional teams (Formulation, QA, QC, Production, and RA teams) to gather and verify technical documents for submission.
Manage lifecycle activities including variations, renewals, and responses to regulatory queries.
Track submission timelines and maintain up-to-date records of product registrations and regulatory statuses.
Evaluate country-specific regulatory guidelines and ensure that product dossiers meet those requirements.
Communicate with local agents, distributors, or regulatory consultants in ROW countries for submission planning and updates.
Assist in compiling GMP/WHO-related documents and site registrations as required.
Stay updated with global regulatory changes and proactively support compliance.
Participate in regulatory audits and inspections by supporting documentation and regulatory readiness.

Assists in analyzing data from clinical trials, including statistical analysis and result interpretation. Requires experience with data analysis tools and strong analytical skills.

Assists in managing and analyzing data from clinical trials, including data entry, validation, and reporting. Requires experience with data management systems and strong analytical skills.

Supports the monitoring and reporting of adverse drug reactions, helps with safety data analysis, and maintains compliance with safety regulations. Requires knowledge in pharmacovigilance and data management skills.

Oversees the collection, management, and analysis of clinical trial data. Ensures data accuracy, integrity, and compliance with study protocols. Requires experience in clinical data management, proficiency with data management systems, and strong organizational skills.