| 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. |
Required Skills
