Amneal Pharmaceuticals - R&D Project Manager - Injectable Development
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About the Role:
- We are seeking a results-driven R&D Project Manager to lead the planning, execution, and delivery of injectable development projects from concept through regulatory approval.
- The role demands strong project governance, cross-functional leadership, and strategic oversight to ensure projects are completed on time, within scope, and in compliance with regulatory standards.
- The R&D Project Manager will serve as the central point of accountability, driving alignment among stakeholders, managing risks, and ensuring effective resource utilization to support the successful commercialization of injectable products.
Key Responsibilities:
Project Leadership & Governance:
- Provide end-to-end leadership of R&D projects, ensuring alignment with business objectives and regulatory requirements.
- Define project scope, objectives, deliverables, timelines, and budgets in collaboration with leadership and stakeholders.
- Establish governance frameworks, reporting mechanisms, and project dashboards for leadership visibility.
Cross-Functional & Stakeholder Management:
- Coordinate across formulation, analytical, clinical, regulatory, manufacturing, and quality teams to ensure smooth project execution.
- Manage external partners, CROs, CMOs, and third-party collaborators, ensuring adherence to timelines and quality standards.
- Act as the single point of accountability for project updates, escalation, and issue resolution.
Planning & Risk Management:
- Lead project planning sessions, develop roadmaps, and allocate resources effectively.
- Identify risks proactively, implement mitigation strategies, and ensure contingency planning.
- Drive decision-making through data-driven insights and structured problem solving.
Compliance & Documentation:
- Ensure regulatory, quality, and compliance standards are met throughout the development lifecycle.
- Maintain complete and accurate project documentation, ensuring audit readiness at all times.
- Support submission readiness activities for regulatory agencies.
Required Skills:
- Strategic Project Leadership Advanced
- Cross-functional Collaboration & Influence Expert
- Regulatory & Compliance Knowledge (Injectables/Pharma) Advanced
- Risk & Resource Management Advanced
- Executive Communication & Reporting Expert
Qualifications:
- Bachelors or Masters degree in Pharmacy (B. Pharma / M. Pharma).
- 7+ years of experience in pharmaceutical R&D project management (injectables preferred).
- Proven experience in leading cross-functional teams and managing multiple complex projects.
- Strong knowledge of regulatory frameworks (USFDA, EMA, etc.) and commercialization pathways.
- Demonstrated ability to manage budgets, timelines, and high-stakes deliverables
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