Drug Regulatory Affairs & Business Development Coordinator

Key Responsibilities

• Review and verify product artwork, QA documents, administrative documents, and other regulatory documents received from manufacturing sites.
• Prepare and compile regulatory dossiers in CTD, ACTD, eCTD, and country-specific formats.
• Coordinate and follow up with manufacturing sites for timely arrangement of required documents, samples, certificates, and other regulatory information.
• Coordinate third-party testing/analysis of product samples and review and verify analytical results.
• Coordinate and conduct finished goods inspection prior to dispatch at manufacturing/warehouse sites, as required.
• Support and coordinate GMP audits, regulatory inspections, and compliance verification of manufacturing facilities.
• Prepare, compile, review, and submit tender-related regulatory and technical documents.
• Track and manage regulatory dossier submissions, approvals, renewals, variations, and other post-registration activities.
• Provide support for regulatory affairs activities and cross-functional projects as required.
• Conduct export market analysis, assess market potential, and support regulatory and commercial strategy planning for new markets.
• Coordinate with the Business Development, Regulatory, QA, Manufacturing, and other cross-functional teams for product registration, market launch, and commercial activities.
• Maintain appropriate regulatory trackers, submission records, correspondence, and status reports to ensure timely completion of assigned activities.

Key Skills & Competencies

• Good understanding of pharmaceutical regulatory affairs and dossier requirements.
• Knowledge of CTD/ACTD/eCTD and country-specific regulatory submissions.
• Good documentation and review skills.
• Strong follow-up, coordination, and communication skills.
• Ability to coordinate effectively with manufacturing sites and cross-functional teams.
• Good analytical and problem-solving abilities.
• Proficiency in MS Office (Word, Excel, PowerPoint).
• Willingness to travel to manufacturing sites, warehouses, and for regulatory/business requirements, as applicable.