14 Oct
|
Orbit Pharmaceuticals
|
Ahmedabad
14 Oct
Orbit Pharmaceuticals
Ahmedabad
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 strong 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 prospect identification to deal closure and execution.
· Lead commercial negotiations including pricing frameworks, licensing structur
📌 Business Development Manager (Ahmedabad)
🏢 Orbit Pharmaceuticals
📍 Ahmedabad