Dra Executive

Job Description

Job Title: Senior Executive Drug Regulatory Affairs (DRA) Job Responsibilities: Prepare and review regulatory dossiers in compliance with country-specific guidelines, including CTD, ACTD, and other regional formats. Manage dossier submissions for new registrations, re-registrations, and product variation filings. Review quality and administrative documents to ensure completeness and accuracy before submission. Conduct literature searches to compile non-clinical and clinical data for dossier preparation. Develop and review SmPCs, Package Inserts, and labeling information in accordance with regulatory requirements and initial dossier submissions. Evaluate and approve artwork for export products. Collaborate with cross-functional departments including QA, QC, Production, ADL, and R&D to streamline regulatory processes. Address and resolve queries from regulatory authorities such as the FDA and other relevant agencies. Maintain communication with international clients regarding dossiers, sample requirements, and regulatory updates. Draft and review applications for product permissions, COPPs, and FSCs. Market Exposure: ASEAN: Philippines, Vietnam, Myanmar, Laos, Cambodia, Thailand Africa: Uganda, Nigeria, Ethiopia, Mozambique, Tanzania, Cameroon, Ivory Coast, Benin, Burundi, Togo, Congo, ZaZiBoNa, South Africa LATAM: Peru, Ecuador, Bolivia, Guatemala, Nicaragua, Costa Rica CIS: Kyrgyzstan, Uzbekistan, Russia, Ukraine Other Regions: Georgia, Sri Lanka, Azerbaijan