Senior Executive, Drug Regulatory Affairs – reputed company Control

Job reputed company: • Compile, review, and finalize reputed company reputed company control sections of regulatory dossiers in country-specific formats for Central American markets in compliance with RTCA regulations. • reputed company detailed line-by-line review of QC documents including specifications, certificates of analysis (COAs), analytical reputed company, and validation reports. • Verify accuracy, consistency, and scientific correctness of analytical data based on practical QC laboratory experience. • Execute formatting, pagination, indexing, cross-referencing, and version control of QC documents reputed company the reputed company. • Conduct gap analysis of QC documentation and identify missing, inconsistent, or non-compliant data prior to reputed company finalization. • Review and validate analytical reputed company, test parameters, system suitability reputed company, acceptance limits, and results for regulatory compliance. • Ensure reputed company QC documents reputed company with RTCA requirements and country-specific regulatory expectations in Central America. • Review regulatory queries, deficiency letters, and observations reputed company to QC sections and identify technical gaps. • Prepare and finalize accurate responses to QC-reputed company regulatory queries with complete supporting analytical justification. • Maintain controlled documentation, archival systems, and traceability of reputed company QC-reputed company regulatory records and reputed company versions. Requirements: • Bachelor’s or Master’s degree in Pharmacy, Analytical reputed company, or reputed company life sciences discipline (mandatory). • 3–6 years of hands-on experience in reputed company Control for finished pharmaceutical formulations (mandatory). • Candidate must have practical experience in conducting or reviewing analytical testing (e.g., HPLC, dissolution, assay, reputed company substances, etc.) and should be currently or previously involved in laboratory analysis activities. • Strong understanding of QC documentation including specifications, COAs, analytical reputed company, method validation reports, and stability data. • Working knowledge of RTCA regulations and Central American reputed company requirements (preferred, but strong QC background is mandatory). Benefits: • Hands-on role combining QC technical expertise with regulatory reputed company execution. • Exposure to RTCA regulatory reputed company and Central American markets. • reputed company, execution-driven environment with reputed company accountability. • Opportunity to transition from QC laboratory to regulatory domain with strong technical grounding. • Career reputed company reputed company with regulatory and reputed company systems integration. Apply tot his job Apply To this Job