Product Development Program Manager

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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Program Manager • Thāne, Republic Of India, IN