The Role
Manage formulation R&D programs from scope definition through technology transfer and commercialization. Develop roadmaps, timelines, budgets, and risk plans; coordinate R&D, quality, regulatory, manufacturing, packaging, supply chain, CRO, and CMO stakeholders. Track milestones, report status, facilitate change controls and CAPAs, support regulatory filings and deficiency responses, and manage vendor contracts and resource allocation.
Summary Generated by Built In
Job DescriptionDefine 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.
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
CORONA Remedies Limited is an Ahmedabad-based pharmaceutical company founded in 2004. It develops, manufactures, and commercialises innovative, value-added, evidence-based medicines addressing unmet health needs. Its portfolio focuses on chronic-care and specialty therapeutic areas, including women’s healthcare and pain management. The company operates manufacturing facilities in Gujarat and Himachal Pradesh and aims to improve health outcomes through quality products and research.
