Project Management Lead - UK Based Pharma Company

B&S Group; Vadodara; In loco; INR 2.500.000 - 4.000.000; Tempo pieno

Descrizione del lavoro

B&S Group in Vadodara, India seeks an experienced R&D Project Manager to lead complex pharmaceutical initiatives, delivering governance, milestones, and clear decisions across functions. You will ensure alignment with strategic priorities and drive transparency in project health and resource allocation.

Responsibilities span initiation to regulatory submission, manufacturing readiness, technology transfer and commercialization, with emphasis on CRO/CMO partnerships, budgets and continuous

Competenze

• Pharma R&D PM with product development, clinical/BA-BE, regulatory, manufacturing, scale-up experience.
• Experience managing CROs, CMOs, CDMOs and external partners.
• Strong governance, risk management and negotiation skills.
• Strategic portfolio-level focus with hands-on project execution.

Mansioni

• Develop and maintain project frameworks covering initiation, planning, execution, and closure.
• Integrate functions into aligned project plans; manage critical paths and risks.
• Lead CRO/BA-BE projects including feasibility, contracts, and regulatory documentation.
• Lead in-house R&D-to-manufacturing projects including trial scale-up and readiness.
• Manage CMO/CDMO partners through contracting, tech transfer, manufacturing, and validation.
• Provide senior-management reporting on health, risks, and dependencies.

Conoscenze

R&D project management

Portfolio management

Regulatory knowledge

Stakeholder management

MS Project / Smartsheet

Strumenti

MS Project

Smartsheet

Descrizione del lavoro

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 escal... 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.
• Strong 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