Lead – Regulated API Business Development

Lead – Regulated API Business Development

Location: Mumbai
Reporting To: Managing Director
Experience: 12+ years
Industry: Regulated APIs / Pharmaceuticals

Chemco is looking for a senior pharmaceutical business development professional to build and scale a focused portfolio of regulated APIs in the Indian market.

This role requires a candidate who understands how regulated API business is actually developed—from identifying the right molecule and customer, through R&D evaluation, regulatory review, supplier qualification and audit, to commercial supply.

The candidate must bring an established network across leading Indian pharmaceutical companies and should be capable of independently generating and converting business.

This is not a lead-generation role. It is a full-cycle technical-commercial business development role.

Key Responsibilities

1. Molecule-to-Customer Mapping

• Map the API and intermediate portfolio against Indian pharmaceutical companies by molecule, dosage form and target market.
• Identify which companies are:
• Existing formulators of the molecule
• Developing the molecule
• Filing for regulated markets
• Looking for an alternate API source
• Evaluating a second-source strategy
• Prioritise opportunities based on commercial potential, regulatory status, competitive intensity and likelihood of qualification.

2. New Business Development

• Open new accounts using existing industry relationships.
• Develop opportunities across regulated APIs, advanced intermediates and selected custom-manufacturing requirements.
• Generate qualified RFQs rather than generic inquiries.
• Identify opportunities for:
• New supplier qualification
• Alternate-source development
• Second-source approval
• New product launches
• Capacity-risk mitigation
• Regulatory-market expansion

3. Technical-Commercial Account Development

The candidate must be comfortable discussing:

• API specifications
• COAs
• Impurity profiles
• Residual solvents
• Particle-size requirements where relevant
• Polymorph / solid-state requirements where relevant
• Stability data
• Analytical-method requirements
• Manufacturing-site qualification
• Change-control expectations
• Regulatory documentation availability

The person should be able to understand the customer’s technical requirement, determine whether the opportunity is commercially viable, and coordinate the appropriate technical team.

4. Regulatory Coordination

• Understand and discuss:
• USDMF / DMF
• CEP
• ASMF where applicable
• Letter of Access / Letter of Authorisation
• Customer-specific regulatory documentation
• Vendor registration requirements
• Site-specific regulatory filings
• Coordinate regulatory questions between the customer and relevant technical/regulatory teams.
• Track qualification and filing status molecule by molecule.

5. Customer Qualification Management

Own the commercial side of the complete qualification cycle:

Opportunity → NDA → Documentation → Sample → Analytical Evaluation → R&D Trial → QA Review → Audit → Vendor Approval → Filing / Registration → Commercial Supply

The candidate should actively track each stage and remove bottlenecks.

6. Key Account Management

Develop relationships across multiple functions within each strategic account:

• API Procurement
• Strategic Sourcing
• R&D / Formulation Development
• Regulatory Affairs
• Quality Assurance
• Vendor Qualification
• Supply Chain
• Portfolio / Business Development

The candidate should not depend on a single procurement contact.

8. Market & Competitor Intelligence

Maintain molecule-level intelligence on:

• Existing Indian and international suppliers
• Customer-approved sources
• Alternative manufacturers
• Indicative market pricing
• Regulatory positioning
• Supply disruptions
• Capacity constraints
• Customer dissatisfaction with incumbent suppliers
• Upcoming patent expiries and generic-development opportunities

The expectation is to convert market intelligence into actionable business opportunities.

The role will involve a regulated API and intermediate portfolio covering multiple therapeutic and chemistry areas.

Candidate Profile

The ideal candidate should have:

• 12–18+ years of API / pharmaceutical intermediate business development experience.
• Strong experience selling into regulated pharmaceutical companies.
• Existing relationships with senior procurement, R&D, QA and RA personnel.
• Proven experience taking an API opportunity from initial discussion to commercial supply.
• Experience in customer qualification and supplier approval cycles.
• Strong understanding of regulatory-market API business.
• Experience handling technical-commercial negotiations.
• Ability to independently create business rather than depend on inbound inquiries.
• Strong understanding of the Indian generic pharmaceutical landscape.
• High commercial ownership and entrepreneurial mindset.

Mandatory Interview Evidence

Key Performance Indicators

Performance will be evaluated on:

• New revenue generated.
• New customers opened.
• New molecule/customer combinations qualified.
• Number of active technical evaluations.
• Number of successful vendor approvals.
• First commercial purchase orders.
• Incremental business from existing accounts.
• Value of qualified pipeline.
• Conversion ratio from sample to commercial business.
• Repeat and recurring business.

Compensation

Competitive Fixed CTC + Significant Performance-Linked Variable Incentive

The variable component will be linked to actual commercial conversion and revenue generated.

Higher incentives will apply to:

• New customers.
• New molecules in existing accounts.
• New supplier approvals.
• Incremental business over existing baseline.
• Large strategic account wins.

The structure will offer substantial upside for high performers.

Ideal Candidate

We are looking for someone who can take a regulated API portfolio and immediately answer:

• Which Indian companies are using these molecules?
• Who are the current API suppliers?
• Which accounts are actively developing alternate sources?
• Who in procurement, R&D, QA and RA needs to be approached?
• What documentation will be required?
• What is preventing supplier qualification?
• What will it take to convert the opportunity into a commercial PO?

The right candidate should already have the relationships, technical understanding and commercial discipline to answer these questions and act on them.

Pay: From ₹80,000.00 per month

Benefits:

• Health insurance
• Leave encashment
• Paid sick time
• Paid time off

Application Question(s):

• Please share your existing business relationships with big pharma companies.

Tell us which companies you have existing contacts in.

Education:

• Master's (Required)

Experience:

• Pharmaceutical sales: 10 years (Required)

Willingness to travel:

• 100% (Required)

Work Location: In person