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 & P&L;: Develop pricing strategies accounting for duties, taxes, and distribution margins. From Year 2, own international P&L;, revenue targets, marketing spend, and overall growth.

5. Team Leadership & Governance

- Team Building: Build regional business teams, define operating models (in-house vs. external partners), and establish an in-house Regulatory Affairs team.
- Executive Liaison: Work directly with promoter directors on market risks, investment priorities, and growth plans. Present regular board updates on market entry, pipeline, margins, and risks.

Qualifications & Experience

- Experience: 10–15 years in pharmaceutical formulations, with a core focus on international exports. Proven ownership of export business in 2 regions (Africa, LATAM, Middle East/GCC, CIS/Central Asia, SE Asia, Oceania).
- Regulatory Expertise: Hands-on experience registering products with 2 non-Indian regulatory authorities. Practical knowledge of CTD/ACTD dossiers, COPP/CPP, GMP certification, stability, and BE requirements.
- Commercial Track Record: Direct experience negotiating Indian CMO/loan-licence agreements. Measured success in managing export turnover, distributor sales, tenders,



landed costing, and international pricing models.
- Leadership & Logistics: Experience building recent international markets and managing cross-functional/country teams. Willingness to travel internationally (~1 week/month) and work from New Delhi.

Skills & Competencies

Must-Have Skills

- Strategy & BD: Formulations exports, emerging-market business development, distributor management, and P&L; ownership.
- Regulatory: International product registrations, CTD/ACTD dossiers, COPP/CPP, GMP, and stability documentation.
- Operations: CMO/loan-licensing qualification, costing, margin management, commercial negotiations, credit terms, and payment risk management.
- Leadership: Board-level communication, strategic decision-making, team leadership, and market feasibility assessment.

Good-to-Have Skills

- Regional & Languages: African market expertise (particularly Francophone West Africa); working knowledge of French, Spanish, or Portuguese.
- Regulatory & Data: Exposure to Ghana FDA and other African authorities; familiarity with IQVIA/IMS and import-trade data.
- Scale & Channels: Experience building export markets from scratch, managing regional heads, and executing institutional procurement/tenders or private-label supply.

Profiles That May Not Be Suitable

- Candidates limited to APIs, bulk drugs, or intermediates.
- Candidates with primary US/EU experience lacking emerging-market exposure.
- Candidates who only managed established distributors without building new markets.
- Candidates whose regulatory experience was restricted to coordination without technical dossier involvement.
- Candidates lacking measurable ownership of international business results.

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