Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control, secure record-keeping, and familiarity with electronic submission platforms (e.g., eCTD tools). Familiarity with ONDLS Portal
We are seeking a motivated and detail-oriented individual to join our pharmaceutical manufacturing unit as a Stores Assistant. The role involves managing daily store operations, including receiving, issuing, and maintaining raw materials, packing materials, and finished goods in compliance with GMP requirements. Key Responsibilities: Handle material receipts and issue as per standard operating procedures. Maintain accurate inventory records in the ERP or manual system. Ensure proper labeling, storage, and segregation of materials. Coordinate with production, QA, and purchase departments for material availability. Support periodic stock verification and reconciliation.