Assistant Manager – Regulatory Affairs

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Rhydburg

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 1987

💊 Pharmazie

🤝 B2B

Pharmaceuticals • B2B

Rhydburg ist ein Hersteller von Fertigarzneimittel-Formulierungen und führender pharmazeutischer Exporteur und Lieferant von Generika, gegründet im Jahr 1987. Das Unternehmen bietet Vertragsfertigung, institutionelle und direkte Marktverteilung sowie Lizenzierungsoptionen in verschiedenen therapeutischen Bereichen an und stellt Tabletten, Kapseln, Injektionen, orale Flüssigkeiten, Salben und Beutel bereit. Rhydburg betont die Einhaltung internationaler Standards (einschließlich WHO-GMP) und verfügt über mehrere behördliche Zulassungen für globale Märkte, was es als Partner für öffentliche Gesundheitsbehörden und kommerzielle Kunden weltweit positioniert.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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.