Senior Executive or Asst Manager For Formulation Project Management

Biophore; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Biophore in Hyderabad, India, is seeking an experienced Project Management professional for Formulation R&D. The role focuses on reviewing BD/Portfolio proposals, estimating budgets and timelines, and coordinating cross-functional teams to finalize RM/PM/analytical requirements.

You will drive project plans, track milestones, and ensure timely dossier filing, regulatory submissions, and FDA query responses, while liaising with CMOs and RA teams to maintain schedules and budgets.

Responsibilities

• 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.
• 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.

Job description

Job Responsibilities

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.
• 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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