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.