Assistant Manager – Regulatory Affairs

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🕒 March 19

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Rhydburg

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1987

💊 Pharmaceuticals

🤝 B2B

Pharmaceuticals • B2B

Rhydburg is a finished-dosage formulations manufacturer and leading pharmaceutical exporter and generic medicine supplier founded in 1987. The company provides contract manufacturing, institutional and direct-to-market distribution, and out-licensing solutions across diverse therapeutic areas, offering tablets, capsules, injections, oral liquids, ointments and sachets. Rhydburg highlights compliance with international standards (including WHO-GMP) and holds multiple regulatory approvals for global markets, positioning itself as a partner for public health agencies and commercial clients worldwide.

📋 Description

• Independently compile, review, and finalize complete regulatory dossiers in country-specific formats for Central American markets in compliance with RTCA regulations. • Perform detailed line-by-line review of all dossier components including administrative, quality, and labeling documents to ensure zero error and full regulatory compliance. • Review and validate regulatory master documents including specifications, COAs, stability data, manufacturing records, and technical reports prior to dossier inclusion. • Execute dossier compilation activities including formatting, pagination, indexing, cross-referencing, and strict version control without dependency on external teams. • Conduct comprehensive RTCA and country-specific gap analysis on dossiers and master documents and ensure complete closure before submission. • Take full ownership of dossier readiness, ensuring that all documentation meets country-specific authority expectations without rework. • Review and finalize electronic and physical dossier packages strictly as per submission requirements of each Central American country. • Analyze regulatory queries, deficiency letters, and observations and perform technical review of responses before submission. • Prepare and finalize high-quality regulatory query responses with complete justification and updated documentation. • Manage, supervise, and review the work output of a team of 4–5 members across QA, QC, Formulation Development, and Manufacturing functions to ensure dossier accuracy and completeness.

🎯 Requirements

• Bachelor’s or Master’s degree in Pharmacy or a related life sciences discipline (mandatory). • 5–8 years of hands-on experience in pharmaceutical regulatory affairs with strong exposure to dossier compilation and review. • Strong working knowledge of RTCA regulations and country-specific dossier formats used in Central America (mandatory). • Demonstrated expertise in reviewing regulatory master documents (specifications, COAs, stability, manufacturing data) with high accuracy. • Proven ability to independently handle dossier compilation and lead a cross-functional team of 4–5 members ensuring delivery without dependency.

🏖️ Benefits

• High ownership role with direct responsibility for dossier compilation, review, and submission quality. • Exposure to RTCA regulatory framework and Central American pharmaceutical markets. • Structured, execution-driven regulatory environment with clear accountability. • Cross-functional leadership exposure across QA, QC, R&D, and Manufacturing teams. • Strong career progression aligned with international regulatory operations.