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