Key Responsibilities
1. Global Market & Portfolio Strategy
• Strategy & Prioritisation: Develop international export strategy across Africa, LATAM, Middle East, CIS/Central Asia, SE Asia, and Oceania. Prioritise or defer markets based on import data, competition, registration costs, timelines, payment risks, and profitability.
• Portfolio Development: Select molecules, strengths, pack sizes, brands, and presentations. Prepare business cases covering registration costs, working capital, landed costs, margins, and payback.

2. Regulatory Affairs & Product Registrations
• End-to-End Registrations: Lead international filings (dossiers, submissions, samples, deficiency responses). Review and approve CTD/ACTD dossiers, COPP/CPP, GMP certificates, and stability data.
• Ghana FDA Transfer: Drive the change of applicant and brand transfer for 26 products registered with Ghana FDA.
• Compliance & Partners: Manage regulatory consultants and in-country partners to ensure filing quality, timeline compliance, variations, and renewals.

3. Contract Manufacturing & Supply Chain




• Vendor Qualification: Identify, evaluate, audit, and qualify Indian CMOs based on GMP compliance, regulatory history, quality systems, export capabilities, and stability testing.
• Commercial Agreements: Negotiate loan-licence and CMO agreements (pricing, MOQs, lead times, supply commitments).
• Costing & Quality: Own product costing from ex-factory to landed cost and local pricing. Establish standards for batch documentation, CoAs, artwork, shelf life, and market complaints.

4. International Business Development & Commercial Operations
• Route to Market: Design market entry via MAHs, distributors, private labels, direct imports, and tenders. Build relationships with international distributors, wholesalers, and institutional buyers.
• Commercial Negotiations: Negotiate distribution agreements, credit terms, and payment security. Identify near-term revenue options while registrations are pending.
• Pricing

📌 Head of International Business (India)
🏢 DU Squad
📍 India