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Pharmaceutical Project Lead

Pharmaceutical Project Lead

Rubicon Research LimitedThāne, Republic Of India, IN
2 days ago
Job description

We are seeking an experienced and proactive Project Manager to lead the end-to-end execution of pharmaceutical development and commercialization projects, specifically for Solid Oral Dosage Forms and Liquid Orals . The selected candidate will manage cross-functional coordination from product development, technology transfer, regulatory filing to Approvals , ensuring all project milestones are delivered on time, within scope, and in full compliance with business and regulatory requirements.

Skills and Competencies :

  • Deep understanding of pharmaceutical product development, technology transfer & Familiarity with global regulatory frameworks and dossier submission processes
  • Strong competency in project planning, risk management, and cross-functional leadership .
  • Proficiency in Microsoft Project, Excel and PowerPoint for real-time project tracking and reporting.
  • Excellent stakeholder management, communication, negotiation and leadership skills .
  • Highly organized, proactive and solution-focused approach to project management.

Key Attributes :

  • Collaborative and team-oriented leadership style .
  • Strong analytical thinking and problem-solving capabilities.
  • Ability to perform effectively under tight deadlines in a regulatory-compliant environment .
  • High degree of ownership, accountability, and customer-centric mindset .
  • Key Responsibilities :

  • Lead the planning, execution, and delivery of pharmaceutical projects — encompassing Formulation Development, Analytical Development, Regulatory Filing, Manufacturing, and Supply Chain — from initiation through Product Approval.
  • Develop and maintain comprehensive project plans including timelines, milestones, resource allocation and risk mitigation strategies using standard project management tools.
  • Coordinate cross-functional teams including R&D, Regulatory Affairs, Quality Assurance, Production, Supply Chain, and Business Development to ensure effective collaboration and timely execution.
  • Manage technology transfer activities from R&D to manufacturing, ensuring robust scale-up, validation, and readiness for commercial production.
  • Serve as the central communication point for internal teams and external partners, ensuring alignment on project goals, timelines, and deliverables.
  • Ensure regulatory submission preparedness for assigned projects and provide active support during dossier filing and query resolution for designated markets.
  • Identify potential risks, establish risk mitigation strategies , and ensure early resolution to maintain project timelines and objectives.
  • Monitor project budgets and resource allocations to ensure optimal utilization, escalating deviations where necessary to maintain alignment with organizational goals.
  • Organize and facilitate regular project review meetings ;
  • prepare clear, data-driven status reports and dashboards for senior management.

  • Ensure strict compliance with GMP, global regulatory guidelines (USFDA, EMA, WHO, MHRA, etc.) , and internal quality standards throughout the project lifecycle.
  • Experience required 17 to 20 years
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    Project Lead • Thāne, Republic Of India, IN

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