Manager

Job Description

Designation: Manager - Project Management

Office Location: Andheri, Mumbai

Position description: Primarily responsible for project managing generic / complex generic R&D projects that are in-licensed, co-developed & tech-transferred to CMO’s, manage new product launches and alliances for US market.

Primary Responsibilities

• Primarily a techno-commercialrole for project managing generic / complex generic projectsfor USmarket. Lead techno-commercial evaluation of new product opportunities, technology platforms, CDMO’s, CRO’s.
• Provide technical inputs on drug development, CMC, non-clinical & clinical aspects for complex generic products –: in-house & licensed (in/out).
• Understand, communicate and provide perspective on the views of external experts / regulatory agencies, relevant to the project’s development strategy - highlight risks and risk mitigation strategies.
• Define, establish & implement the Project Management process for the said portfolio; establish Project review mechanisms & conduct of project within approved budgets – ensure successful completion of project milestones as per project plans.
• Project manage CMO & tech-transfer projects – Techno-commercial evaluation of CMO/CDMO/CRO; Preparing RFP, Contracting, Project execution & tracking.
• Manage new product launches for partnered products – Provide end to end visibility of launch plans to all stakeholders and ensure timely execution of plans.
• Alliance management of IL/CDMO partners.
  
  

Educational Qualifications

Minimum of a Bachelor Degree in Pharma/ Biotech preferably with an MBA. PMP certification is an added advantage.

Required Work Experience

• Must possess experience of 10 - 12 years in R&D / Regulatory related roles with good exposure to technology, product assessments, commercial aspects, etc.
• Must have exposure to US/EU Regulatory environment, experience in complex technology platforms (NDDS) will be an advantage.
• Exposure to BD and/or Alliance management would be an added advantage.
  
  

Key Interfaces

External

Licensing partners, CMO/CDMO, Consultants, Design houses, Contract Manufacturers, Regulatory Consultants, Clinical Consultants.

Internal

R&D, Regulatory affairs, Clinical Services, QA, BD & Portfolio team.

Required Knowledge & Skills

Understanding of drug development across R&D/ Manufacturing/ Clinical aspects.

Good analytical & communication skills.

Project Management tools & Techniques.

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