- Plan and manage end-to-end project timelines using MS Project with defined milestones, dependencies, and resources for Ex-US regulated and emerging markets.
- Prepare, update and monitor project timelines, milestones and submission plans project tracking systems
- Ensure timely updating and closure of project activities in Parivartan as per organizational requirements.
- Coordinate with cross-functional teams including Formulation Development, Analytical Development, Regulatory Affairs, Packaging Development, Supply Chain, Procurement, QA and Manufacturing.
- Track project progress and ensure adherence to committed timelines and business goals.
- Identify project risks, bottlenecks and propose mitigation plans for smooth project execution.
- Coordinate dossier compilation, submission readiness, deficiency response, and approval tracking activities.
- Generate project status reports, KPI updates,
and management presentations from Parivartan/D-Cube systems.
- Interact with external partners, CROs, CMOs, consultants and regulatory agencies whenever required.
- Conduct weekly/fortnightly review meetings with cross-functional stakeholders to assess project health and progress
- Ensure accurate and timely updates of project status in the centralized Project Tracker
- Apply strong understanding of pharmaceutical product development lifecycle for effective project planning and execution
Qualifications & Pre-Requisites
M. Pharm / Relevant Experience
Additional notes
- Experience from similar positions in the industry
- Exposure to regulated and semi-regulated international markets.
- Valuable understanding of pharmaceutical development lifecycle and regulatory submission processes.
- Experience in handling project management systems such as MS Project or equivalent platforms.
- Should be able to use MS Project and MS Excel efficiently
- Should be very well versed with entire pharmaceutical product development process
📌 Assistant Manager (India)
🏢 Rubicon Research
📍 India
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