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.

Work arrangement
No