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Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Coordinating overall project development for the regulated market, especially ANDA's for US filing- Responsible for coordinating the development of Solid, Liquid, Semi-solid pharmaceutical Products for the US, EU & any other Global Market through CROs and R & D in China- Start to End Project tracking and control to ensure the projects are delivered in the specific timeline, budget and quality.- Assist department head to complete annual plan of R & D formulation and assist for selection of new projects for development- Conduct internal project review meetings with respective departmental head to identify & highlight any blocking issues in the project in order to resolve them- Evaluating patents and literature prior arts for preparing of Project Strategy & Project proposal for determining timelines for entire project.- Evaluating & facilitating Pilot & Pivotal BE studies. Study plan finalization, considering the product need and its cost implication on budget of project.- Closely monitor the development work and discuss R&D trial outcome with functional heads of CROs to ensure technical support to the project.- Coordinate multidisciplinary activities to ensure that the project deliverables are met within timeline.- Review of technical documents such as BE protocols, PDR, Specifications, TTD package etc.- Facilitate dossier filing activity and co-ordinate to respond on deficiency letters within timeline.Minor technical responsibilities- Address CROs meetings and teleconferences for having timely project discussion and accordingly capture timelines in Action Plans.- Preparation of Documents like TT Action plan, Proposals, Project Reports etc.
Degree: M.Pharm. (Pharmacy)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 10-12


Bio-Statistician | Bio/Pharma Informatics | Goods Manufacturing Practices (GMP)
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