Manager

• Primarily a techno-commercial rolefor project managing generic / complex generic projects for US market.Lead techno-commercial evaluation of new product opportunities, technologyplatforms, CDMOs, CROs.
• Providetechnical inputs on drug development, CMC, non-clinical clinical aspectsfor complex generic products : in-house licensed (in/out).
• Understand, communicate and provide perspective on theviews of external experts / regulatory agencies, relevant to the projectsdevelopment strategy - highlight risks and risk mitigation strategies.
• Define, establishimplement the Project Management process for the said portfolio;establish Project review mechanisms conduct of project within approvedbudgets ensure successful completion of project milestones as per projectplans.
• Project manage CMO tech-transfer projects T echno-commercialevaluation of CMO/CDMO/CRO; Preparing RFP, Contracting, Project execution tracking.
• Manage new product launches for partnered products Provideend to end visibility of launch plans to all stakeholders and ensure timely execution of plans.
• Alliance managementof IL/CDMO partners.

• Mustpossess experience of 10 - 12 years in RD / Regulatory related roles withgood exposure to technology, product assessments, commercial aspects, etc.
• Musthave exposure to US/EU Regulatory environment, experience in complex technologyplatforms (NDDS) will be an advantage.
• Exposureto BD and/or Alliance management would be an added advantage.

Understandingof drug development across RD/ Manufacturing/ Clinical aspects .

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