Medley Pharmaceuticals - General Manager - International Business Development - US Market

GM - IB (US) (20-25 yrs)

Scope of Work:

We are looking for a dynamic and experienced General Manager International Business Development to lead the expansion of our pharmaceutical formulations business in the US market. The candidate will be responsible for developing strategic business opportunities, managing key customer relationships, driving product commercialization, and achieving revenue growth in compliance with US FDA regulations.

The role requires strong expertise in the US formulations market, including generic products, ANDA commercialization, contract manufacturing, product licensing, and strategic partnerships.

Key Performance Indicators:

Business Development & Market Expansion:

- Develop and execute business strategies to expand the companys pharmaceutical formulations business in the US market.

- Identify and onboard new customers, distributors, marketing partners, and strategic alliances.

- Explore opportunities for generic formulations, branded generics, injectables, oral solids, specialty formulations, and contract manufacturing (CMO/CDMO).

- Conduct market research, competitor analysis, and product opportunity assessments.

- Develop annual business plans and growth roadmaps for the US formulations segment.

Product Commercialization & Portfolio Management:

- Coordinate with Regulatory Affairs and R&D teams for ANDA pipeline planning and commercialization strategies.

- Evaluate product selection based on market potential, competition, pricing, and profitability.

- Support launch planning and lifecycle management for US products.

- Monitor market trends, product performance, and customer requirements.

Customer & Key Account Management:

- Build and maintain strong relationships with US pharmaceutical companies, distributors, buying groups, strategic sourcing partners, and licensing partners.

- Lead commercial negotiations, pricing discussions, supply agreements, and contract finalization.

- Ensure high levels of customer satisfaction and long-term business retention.

Regulatory & Compliance Coordination:

- Work closely with Regulatory Affairs, Quality Assurance, and Supply Chain teams to ensure compliance with US FDA requirements, cGMP standards, and serialization norms.

- Support regulatory submissions, audits, and product approvals.

Strategic Alliances & Licensing:

- Identify licensing-in and licensing-out opportunities for formulations.

- Develop strategic partnerships for market access and portfolio expansion.

- Evaluate business proposals, due diligence reports, and partnership models.

Financial & Business Performance:

- Drive revenue growth and profitability for the US formulations business.

- Prepare sales forecasts, business projections, and budget plans.

- Monitor KPIs including sales growth, gross margins, product launches, market penetration, and customer acquisition.

- Present business reviews and strategic updates to senior management.

Competencies:

- Strong understanding of US pharmaceutical formulations market, ANDA filing and commercialization, US FDA regulations, generic pharmaceutical business, CDMO/CMO business models, strategic business planning, international sales and negotiations, and market intelligence.

Required Qualification:

- Bachelors degree in pharmacy, Life Sciences, or related field.

- MBA in International Business / Marketing preferred.

- 18 - 20+ years of experience in pharmaceutical international business development.

- Minimum 5 years of experience handling the US formulations market.