Assistant General Manager
Assistant General Manager
rubicon research limited- Posted 11 hours ago
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Job Description
Purpose
We are seeking an experienced and proactive Sr.Project Manager to lead the end-to-end execution of pharmaceutical development projects, all dosage forms. 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.
Position / Job Title
Assistant General Manager- Project Management
Department
Project Management
Reporting To
Senior General Manager
Location
Thane
Years Of Experience
10-14 years of industry experience, with a minimum of 7+ years specifically in pharmaceutical project management.
Job Responsibilities / Deliverables
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
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.
We are seeking an experienced and proactive Sr.Project Manager to lead the end-to-end execution of pharmaceutical development projects, all dosage forms. 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.
Position / Job Title
Assistant General Manager- Project Management
Department
Project Management
Reporting To
Senior General Manager
Location
Thane
Years Of Experience
10-14 years of industry experience, with a minimum of 7+ years specifically in pharmaceutical project management.
Job Responsibilities / Deliverables
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
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.
More Info
Key Skills
cross-functional leadership
pharmaceutical product development
dossier submission processes
global regulatory frameworks
About Company
Skills:
analytical capability , Litigation Management, Legal Drafting, Legal risk assessment, Court procedures, Tracking legislative amendments, Navigating statutory databases, Institutional legal governance frameworks, Legal MIS reporting systems, Knowledge of litigation processes, Technology adaptability, Data orientation, Legal strategy, Advanced legal research, Process Orientation, Vetting
Skills:
Formulation Development, QBD principles, Pilot BE batches, Batch manufacturing and process validation, Optimization of oral solid and liquid dosage forms, Technology Transfer, Lab GMP system and practices
Skills:
Ms Excel, Customer service, Competitor Analysis, Market trends, After sales services, Customer Retention, Strategies, Reporting