31 Jul
|
Inventia Healthcare
|
Alibag
31 Jul
Inventia Healthcare
Alibag
Job DescriptionKey Responsibilities
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- Lead and manage team of 2 Project Management professionals for end-to-end pharmaceutical development projects from project initiation through dossier filing and regulatory approval.
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- Define R&D; project scope, objectives, deliverables, timelines, resource requirements, and critical milestones for each assigned project.
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- Develop, maintain, and monitor integrated project plans to ensure timely achievement of development, regulatory, and commercial objectives.
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- Act as the central point of coordination between cross-functional teams including Formulation Development, Analytical Development, Regulatory Affairs, Procurement, Packaging Development, Manufacturing, Quality Control, Quality Assurance and Business Development.
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- Conducting R&D; MIS reporting, delivering structured project updates and risk summaries to senior management and investors.
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- Manage project budgets including OPEX, CAPEX, COGS, and Annual Operating Plans (AOP), ensuring efficient utilization of resources and adherence to financial targets.
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- Prepare and review R&D; project cost estimates for current opportunities shortlisted by the Portfolio team, supporting portfolio prioritization, business case evaluation,
and go/no-go decisions.
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- Serve as the primary technical point of contact for clients, partners, CMOs, ensuring effective communication and issue resolution.
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- Managed and synchronized timelines and key milestones across PE and QP laboratories and the secondary packaging site, driving cross-functional collaboration and on-time project delivery.
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- Develop annual regulatory operating plans by forecasting dossier submissions, approvals, and lifecycle management activities across SRA countries, LATAM, MEA, and Asia, ensuring alignment with portfolio priorities and business objectives.
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- Lead monthly regulatoryportfolio reviews by reporting achievement against filing and approval targets, providing detailed analysis of missed commitments, underlying causes, resource constraints, regulatory challenges, and recovery plans for management decision-making.
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- Coordinate with Business Development, Portfolio Management, and senior management to assess new opportunities, review project performance, and ensure timely and informed decision-making aligned with business objectives.
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📌 Group Manager- Project Management (Alibag)
🏢 Inventia Healthcare
📍 Alibag