Role Purpose

- Lead the R&D; Project Management function, establish project governance and standardized tools/processes, and provide portfolio-level visibility on progress, priorities, risks, dependencies, resources and decisions.

- Personally, own and deliver strategically important, complex R&D; projects from initiation through development, BA/BE, regulatory submission, manufacturing, technology transfer and commercialization, as applicable.

Key Responsibilities

- Develop and maintain project frameworks covering initiation, planning, execution, monitoring, risk management, escalation, decision-making and closure; drive consistent use of plans, milestone trackers, risk registers, action logs and dashboards.

- Integrate Formulation, Analytical, Regulatory, Clinical/BA-BE, Quality, Manufacturing, Supply Chain and other functions into aligned project plans; manage critical paths, dependencies, issues and recovery actions.

- Lead CRO/BA-BE projects including CRO selection, feasibility, CDA/MSA/contracts, commercial negotiations, study planning, regulatory documentation, BENOC/Test Licence support, CDSCO/DCGI responses, study monitoring and report closure.

- Lead in-house R&D-to-manufacturing; projects including trial/scale-up/process-validation batches, manufacturing readiness, materials, technical documentation, equipment, schedules and resources.

- Manage CMO/CDMO partners from due diligence and selection through contracting, development, technology transfer, manufacturing, validation and commercialization; monitor delivery, quality, cost and supply commitments.

- Own portfolio risk and issue management; establish mitigation/contingency plans, assess change impact and escalate critical risks, delays and decisions requiring senior management intervention.





- Manage project budgets, commercial commitments, milestone payments, invoices and cost optimization with Finance and stakeholders.

- Provide concise senior-management reporting on project health, milestones, critical path, risks, regulatory status, manufacturing readiness, partner performance, budget, dependencies and decisions required.

- Drive continuous improvement, standardization, knowledge sharing and maturity of R&D; project management practices.

Key Accountabilities

- R&D; Project Management function effectiveness and maturity; delivery of strategic portfolio against scope, timeline, cost, quality and regulatory objectives.

- Hands-on ownership of complex projects; effective governance of CRO/CMO/CDMO partners; cross-functional alignment; timely risk/issue resolution; accurate portfolio intelligence to senior management.

Experience & Competencies

- Strong pharmaceutical R&D; project/program management experience across product development, clinical/BA-BE, regulatory, manufacturing, scale-up, process validation, technology transfer and commercialization.

- Experience managing CROs, CMOs, CDMOs and external partners; strong understanding of CDSCO/DCGI processes and pharmaceutical regulatory requirements.

- Solid project governance, portfolio/risk management, commercial/contract management, stakeholder influencing, negotiation, problem-solving and decision-making skills.

- Ability to operate strategically at portfolio level while remaining hands-on in project execution;

experience with Smartsheet, MS Project or equivalent is desirable.

Leadership Expectations

- Ownership • Influence without direct authority • Strategic thinking • Data-based decision making • Governance and accountability • Continuous improvement • Hands-on execution

📌 Project Management Lead - UK Based Pharma Company (Vadodara)
🏢 Bu0026S Group
📍 Vadodara