13 Aug
|
Inventia Healthcare
|
India
13 Aug
Inventia Healthcare
India
Key Responsibilities:
- 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 productive 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, r
📌 Group Manager- Project Management (India)
🏢 Inventia Healthcare
📍 India