Project Manager, Regulatory Compliance Specialist, Operations Management

Job Purpose
To manage end-to-end project completion for Injectable and Ophthalmic products, ensuring timely development, technology transfer, regulatory filings, validation, and commercial launches through effective cross-functional coordination to meet client expectations.

Key Responsibilities
Lead project planning, execution, monitoring, closure, and source change management activities.
Coordinate with R&D, Manufacturing, QA, QC, Regulatory Affairs, Engineering, Supply Chain, and Commercial teams for successful project delivery.
Drive technology transfer, scale-up, validation, and commercialization of products for US and other regulated markets.
Ensure achievement of project milestones and maintain OTIF (On-Time-In-Full) performance above 95%.
Monitor project timelines, identify risks, and implement mitigation plans to ensure timely execution.
Conduct project review meetings and provide timely progress updates to management and customers.
Manage client projects and meeting expectations to partner them as a CMOs, and CDMOs.
Ensure compliance with GMP requirements, regulatory commitments, quality standards, and customer agreements.
Drive validation, and commercialization targets aligned with business objectives.
Escalate critical project and resource issues in a timely manner and drive resolution through cross-functional collaboration.
Qualification & Experience
M. Pharm / Masters in PMP
8–12 years of experience in Project Management, Technology Transfer, Product Development, or Operations in Injectable/Ophthalmic formulations.
Experience in managing projects for USFDA and other regulated markets.
Key Competencies
Project Management
Technology Transfer
Stakeholder Management
Risk Management
Regulatory & GMP Compliance
Leadership & Team Management
Communication & Problem Solving