Rhydburg

Role Description This is a remote position. - 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. Qualifications - 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.

• Drive B2B pharmaceutical expansion across Burkina Faso, Senegal, Ivory Coast, Ghana, Cameroon, Madagascar, and Mauritius. • Appoint and manage commercial agents in Burkina Faso, Senegal, and Ivory Coast to secure structured access to both public tenders and private distribution networks. • Expand private market operations in Ghana, Cameroon, and Madagascar through distributor partnerships and owned registrations. • Develop institutional public procurement access in Mauritius through aligned B2B distributor relationships. • Identify and appoint distributors capable of handling importation, warehousing, tender participation, and supply execution. • Negotiate pricing models, credit terms, commercial margins, and territory responsibilities with distribution partners. • Prepare country-wise revenue forecasts and align demand planning with production and supply chain functions. • Monitor partner performance through CRM reporting, structured review meetings, and revenue tracking metrics. • Conduct competitive intelligence focused on tender behaviour, pricing benchmarks, and private channel positioning. • Strengthen market presence through periodic in-country visits and structured commercial relationship building. • Ensure coordinated internal alignment between regulatory filings and commercial launch timelines.

• Drive B2B pharmaceutical expansion across Peru, Chile, Venezuela, and Bolivia. • Develop structured access to both public procurement systems and private distribution networks in each territory. • Identify, appoint, and manage distributors capable of handling importation, commercialization, and market penetration. • Build institutional participation in public tenders through aligned distributor partnerships and pricing strategy. • Expand private market presence through portfolio positioning and generics commercialization strategy. • Coordinate with Regulatory Affairs for product registrations, approvals, and commercial launch readiness. • Negotiate pricing structures, minimum order quantities, payment cycles, and territory-specific exclusivity. • Prepare country-wise revenue forecasts aligned with production planning and supply chain functions. • Maintain structured CRM reporting covering pipeline movement, forecast accuracy, and revenue realization. • Conduct territory-based competitive benchmarking, tender trend evaluation, and pricing strategy mapping. • Strengthen distributor accountability through performance reviews and revenue growth monitoring. • Travel periodically across assigned countries to expand relationships and reinforce commercial presence.