Manager - Project Management
Aarvi Encon- Posted 7 hours ago
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Job Description
B. Pharm in Pharmaceuticals, 6-8 years of experience in pharmaceutical project management, preferably in injectables. Exposure to cross-functional coordination across R&D, RA, Purchase, Manufacturing and BD. Proven experience working with Contract Manufacturing Organizations (CMOs).Experience in understanding of regulatory submission across Global market Project lifecycle management Regulatory and CMC understanding MIS reporting and data consolidation Cost and budget tracking CMO management and outsourcing Documentation and RFP preparation Cross-functional coordination Client handling and timely update sharing
Conduct Stage Gate reviews and internal team huddles based on project phase. Coordinate with cross-functional teams (FRD, ARD, API, RA, Packaging, Purchase, etc.) for seamless execution. Track and follow up on project activities to ensure completion within agreed timelines. Monitor regulatory filing timelines and escalate delays, if any. Prepare and circulate meeting minutes and action trackers. Maintain and submit monthly MIS reports with high-level project updates by the 15h business day. Organize and lead monthly/bi-monthly MIS meetings for injectable portfolio .Act as point of contact for CMOs; manage weekly/bi-weekly progress calls. Coordinate with external labs, track deliverables, and ensure timelines are met. Prepare and track project cost sheets within 7 days of initiation. Monitor budget utilization and escalate any deviations or overruns. business cases for alternate API vendors when needed. Prepare and issue RFQs for CMO selection; visit CMOs and provide executive summaries. Track and support timely regulatory dossier submissions and MoH interactions. Collaborate in understanding and contributing to QP/PE and CMO agreements.
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Key Skills
regulatory submission
cost and budget tracking
regulatory and CMC understanding
data consolidation
cross-functional coordination
