JB-803-Senior Executive Drug Regulatory Affairs - Formulation Development

This is a remote position. Job Description • Compile, review, and finalize formulation development and manufacturing sections of regulatory dossiers in country-specific formats for Central American markets in compliance with RTCA regulations. • Perform detailed line-by-line review of formulation documents including product development reports, composition, excipient justifications, and process descriptions. • Verify scientific accuracy and consistency of formulation data across development reports, batch records, and dossier documents. • Execute formatting, pagination, indexing, cross-referencing, and version control of formulation-related documents within the dossier. • Conduct gap analysis of formulation and process documentation and identify missing, inconsistent, or non-compliant data prior to dossier finalization. • Review and validate manufacturing process details including batch size, process parameters, critical process controls, and in-process specifications. • Ensure all formulation and manufacturing data complies with RTCA requirements and country-specific regulatory expectations in Central America. • Review regulatory queries, deficiency letters, and observations related to formulation and manufacturing sections and identify technical gaps. • Prepare and finalize responses to formulation-related regulatory queries with complete scientific justification and updated documentation. • Maintain controlled documentation, archival systems, and traceability of all formulation-related regulatory records and dossier versions. Requirements Requirements • Bachelor’s or Master’s degree in Pharmacy or related life sciences discipline (mandatory). • 3–6 years of hands-on experience in either formulation development or pharmaceutical manufacturing for finished dosage forms (mandatory). • Candidate must have practical exposure to activities such as product development, trial batches, scale-up, technology transfer, or manufacturing operations. • Strong understanding of formulation and manufacturing documentation including development reports, composition, manufacturing process descriptions, and batch manufacturing records (BMRs). • Working knowledge of RTCA regulations and Central American dossier requirements (preferred, but strong technical background is mandatory). Benefits Benefits • Hands-on role integrating formulation expertise with regulatory dossier execution. • Exposure to RTCA regulatory framework and Central American markets. • Structured, execution-driven environment with clear accountability. • Opportunity to transition from formulation development to regulatory domain with strong technical grounding. • Career growth aligned with regulatory and product development integration.