Project Management Formulation R&D;
- Review project proposals received from Business Development (BD)/Portfolio Teams, assess feasibility, and prepare preliminary budgets and project timelines.
- Coordinate with CFTs to finalize development quantities for raw materials (RM), packaging materials (PM), and analytical requirements to support budget preparation and project scope finalization.
- Track licensing requirements and their availability, align project timelines, and organize project kick-off meetings.
- Prepare project plans and micro-plans, track milestones, monitor progress, and ensure timely dossier filing.
- Coordinate with SCM, Purchase, and internal/external Alliance Management Teams to ensure timely availability of API, IMP, WS, and RS for development and exhibit batches.
- Coordinate with the API Team to ensure the availability of technical packages and required analytical data.
- Conduct weekly project review meetings,
prepare progress presentations, and communicate project status to stakeholders.
- Identify project risks, assess their impact, and develop mitigation plans to minimize delays.
- Coordinate with Plant/Manufacturing Teams for the smooth execution of scale-up and exhibit batches.
- Coordinate with and support Regulatory Affairs (RA) Teams in technical documentation, ANDA submissions, and timely responses to FDA queries (IRs, DRLs, and CRLs).
- Coordinate with Contract Manufacturing Organizations (CMOs) for proposal evaluation, scope-of-work finalization, cost negotiation, and project execution tracking against agreed timelines.
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Designation
📌 Project Manager (Hyderabad)
🏢 Biophore
📍 Hyderabad