Pharmaceuticals International Business – Head - Business Development & Regulatory Affairs
Business Development Head – Regulatory Affairs & International Markets
Location: Indore,Madhya Pradesh
Employment: Full-time
Reporting to: Managing Director / Directors
Salary: Negotiable, based on experience and capability
About the Company
The Company manufactures pharmaceutical tablets, capsules and ointments, serves government supply markets, and is expanding its international business.
Role Overview
We are seeking an experienced Business Development Head with a strong Regulatory Affairs background to develop international markets, identify pharmaceutical importers and distributors, and coordinate product registrations. The candidate will connect commercial opportunities with regulatory requirements and convert successful registrations into supply agreements and repeat business.
Key Target Markets - Africa, Middle East, Sri Lanka, Asia etc.
Key Responsibilities
* Identify and develop export opportunities across Africa, Asia and other selected international markets.
* Build relationships with importers, distributors, local registration holders and regulatory consultants.
* Assess country-specific registration requirements, costs and timelines before committing to market entry.
* Prepare a product and country registration plan based on demand, commercial potential and manufacturing capabilities.
* Coordinate with RA, QA, QC and Production teams for dossier preparation, submissions, authority queries, renewals and variations.
* Coordinate documentation such as CTD/ACTD dossiers, COPP, GMP certificates, stability data, specifications and approved artwork, as applicable.
* Lead commercial negotiations covering pricing, minimum order quantities, payment terms, registration expenses and distribution arrangements.
* Work with management and legal advisers to define registration ownership, exclusivity, sales commitments and termination terms.
* Develop third-party and contract manufacturing business with domestic and international pharmaceutical companies.
* Track registration progress and coordinate the first commercial order after approval.
* Represent the company at pharmaceutical exhibitions, buyer meetings and business visits.
* Maintain a structured pipeline and report opportunities, registration milestones, sales forecasts and collections to management.
* Recruit, guide and develop the business development team.
Qualifications and Experience
* B.Pharm / M.Pharm; an MBA in International Business or Marketing is preferred.
* Preferably 10–15 years of pharmaceutical experience, including at least 5 years in international business development with substantial regulatory registration exposure.
* Proven experience converting distributor relationships and product registrations into commercial orders.
* Working knowledge of CTD/ACTD dossiers and registration processes in relevant export markets.
* Experience with tablets, capsules, creams, gels and ointments.
* Strong negotiation, communication, planning and team leadership skills.
* Willingness to travel internationally.
* Experience with psychotropic product registrations and applicable import/export permissions will be an added advantage.
* An established network of pharmaceutical importers, distributors and registration partners is preferred.
Key Performance Indicators
* Qualified importer and distributor opportunities developed.
* Commercial agreements signed and active supply accounts established.
* Registration milestones achieved against agreed timelines and budgets.
* Conversion of registrations into first orders and repeat orders.
* Export revenue, profitability and timely collections.
Application
Interested candidates should submit their updated CV, current and expected CTC, notice period, markets handled, and a brief summary of product registrations and export