HR Manager at Yo HR Consultancy
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Assistant Manager/Manager - Project Management - API Business (7-15 yrs)
Assistant Manager/ Manager - Project Management - Api
Location : Mumbai
Experience : 7.0 - 15.0 Years
Must Have :
- Experience in project management of API business
- Experience working with regulatory affairs
Job Description : R&D Program Management
- Project management of New Product Development (NPD) of API projects for US, CAN, EU, Brazil, China, ROW/Emerging markets.
- Preparation of project plan with milestones for process & analytical development, scale up, validation, stability until fling.
- To coordinate between R&D, Manufacturing, Operation and Formulation team/ sites in case of captive API transfers. Ensure integration of necessary information between formulation and API teams on expectation quantity, quality, specs and MOA of API.
- To coordinate and synchronize the transfer of API process from R&D to Operation for smooth tech transfer to the plant (inclusive of raw material availability, analytical method validations, documentation of PV batches)
- To track and monitor activities related to DMF flings and regulatory queries
- Preparation of updates for various R&D and CFT meetings.
- Management Dashboard preparation and circulation on a monthly basis
- Actively engage in vendor development/ qualification and alternate vendor development program
- Ensure that the team completes timely collation of documents needed by Regulatory Affairs for DMF submission.
- Work with Regulatory Affairs to evaluate and assign queries to relevant teams. Provide insights and inputs to aid timely closure.