Project Manager

Position: Project Manager (International Regulatory Affairs & Export Compliance)
Location: Kathmandu, Nepal

Job Description

• Manage international regulatory compliance and export registration requirements for pharmaceutical products.
• Conduct market procurement dynamics analysis including import dependency, demand forecasting, and volume analysis.
• Develop export pricing strategies including CIF/FOB pricing, export costing, and Incoterm selection.
• Oversee CTD/ACTD dossier preparation, variation filings (CMC), and regulatory submissions.
• Coordinate with DDA and other regulatory authorities for COPP and export certifications.
• Handle BA/BE and Biowaiver strategy including gap analysis and waiver eligibility assessment.
• Ensure country-specific export labeling compliance, risk mitigation, and contingency planning.
• Identify focus countries and evaluate distributors, agents, and strategic partners.
• Support contract negotiation including exclusivity clauses, commercial terms, MAA, and termination rights.
• Respond to international technical and regulatory queries from overseas markets.
• Analyze international pharmaceutical tenders and ensure bid preparation and submission.
• Conduct weekly cross-functional meetings with Regulatory, QA, Legal, Finance, SCM, and Logistics teams.
• Organize training on international regulatory updates and team capacity building.
• Recommend high-margin and high-volume product portfolios for export markets.

Tagged as: Kathmandu