Job Description & How to Apply Below
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.
Define R&D project scope, objectives, deliverables, timelines, resource requirements, and critical milestones for each assigned project.
Develop, maintain, and monitor integrated project plans to ensure timely achievement of development, regulatory, and commercial objectives.
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.
Conducting R&D MIS reporting, delivering structured project updates and risk summaries to senior management and investors.
Manage project budgets including OPEX, CAPEX, COGS, and Annual Operating Plans (AOP), ensuring efficient utilization of resources and adherence to financial targets.
Prepare and review R&D project cost estimates for new opportunities shortlisted by the Portfolio team, supporting portfolio prioritization, business case evaluation, and go/no-go decisions.
Serve as the primary technical point of contact for clients, partners, CMOs, ensuring effective communication and issue resolution.
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.
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.
Lead monthly regulatory portfolio 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.
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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