Job Description
Define project scope, timelines, milestones, resources, and risk mitigation plans for each formulation R&D program.
Develop and maintain project roadmaps (short‑ and long‑term) aligned with product strategy and regulatory timelines (EU, ROW and Domestic Market)
Track progress using project‑management tools (e.g., Gantt charts, MS Project), report project status to senior management.
Liaise with R&D, QA/QC, regulatory affairs, manufacturing, packaging, and supply chain to ensure seamless technology transfer, validation, and commercialization.
Coordinate CMOs, and CROs for site transfer projects.
Facilitate technical and quality discussions for change controls, deviations, and CAPAs affecting formulation projects.
Ensure R&D deliverables support regulatory filings including Product Development Reports, Quality Overall Summaries, and CMC sections.
Coordinate with Regulatory Affairs to address deficiencies, provide technical clarifications, and align dossier timelines with project milestones.
Manage R&D budgets, vendor contracts, and resource allocation to optimize project value and cost.
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