Job Role:

Business Development Manager-Regulated Markets

Responsible to:

Head – Business Development / Director

Responsible for:

API Co development Strategic Partnership for Regulated markets

Key Relationships:

Internal R&D;, regulatory, and manufacturing teams

External: Key clients and strategic partners

Scope and Purpose of Role The Business Development Manager will be responsible for driving strategic co-development partnerships across the Regulated markets like EU, US, UK etc, with a solid focus on regulated market entry and long-term value creation. The role will lead the commercialization of the company’s API pipeline through collaborative development models aligned with CEP, USDMF, and other DMF-based regulatory pathways.

The position will play a critical role in establishing and expanding partnerships with pharmaceutical companies for API development, technology transfer, regulatory filings, and integrated API-to-FDF opportunities within the Regulated markets.

Key Responsibilities and Tasks

Key Responsibilities:

· Identify, evaluate, and establish strategic co-development partnerships with pharmaceutical companies across the Regulated Markets like EU, US, UK etc.

· Lead business development activities for API projects aligned with CEP, ASMF, USDMF, and other regulated market requirements.

· Drive and structure co-development models, including risk-sharing, cost-sharing, and long-term supply agreements.

· Collaborate with partners on API development, technology transfer,



and regulatory submission strategies for Regulated Markets.

· Build and manage a strong pipeline of CEP/DMF-based opportunities with clear commercialization pathways.

· Work closely with internal R&D;, regulatory, and manufacturing teams to align on development timelines and filing strategies.

· Support partner engagements across the full lifecycle—from opportunity identification to deal closure and execution.

· Lead commercial negotiations including pricing frameworks, licensing structures, and supply agreements.

· Monitor market trends, patent landscapes, and competitive dynamics to identify high-value co-development opportunities.

· Represent the company at international industry events, conferences (e.g., CPHI), and partner meetings.

Requirements:

· 5–10 years of experience in pharmaceutical business development, with a focus on APIs and regulated markets.

· Strong understanding of CEP, ASMF, USDMF, and regulatory frameworks in Regulated markets like EU, US, UK.

· Proven experience in co-development, licensing, or strategic partnership models.

· Demonstrated ability to manage complex stakeholder relationships and cross-functional collaboration.

Key Skills:

· Strategic partnership development

· Commercial negotiation and deal structuring

· Regulatory and market understanding (UK/EU)

· Strong analytical and opportunity assessment capabilities

· Excellent communication and stakeholder management skills

📌 Business Development Manager (Ahmedabad)
🏢 Orbit Pharmaceuticals
📍 Ahmedabad