Executive - Project Managment

Job Description

Job Summary

The Product Change & Lifecycle Management Coordinator supports end-to-end product lifecycle activities, site transfers, regulatory compliance, and project tracking to ensure timely delivery, quality, and adherence to global standards in pharmaceutical manufacturing.

Job Responsibilities

• Develop and execute comprehensive Product Change Management strategies aligned with business goals and regulatory standards.
• Coordinate cross-functional teams (R&D, Regulatory, Manufacturing, Planning) to ensure seamless product lifecycle management.
• Oversee regulatory submissions, amendments, and renewals throughout the product lifecycle.
• Lead lifecycle activities such as New Source Qualification, Source-Driven Changes, 3P Site transfers, packaging variations, and label updates.
• Ensure compliance with global and local pharmaceutical regulations (GMP, GDP, etc.).
• Prepare and monitor monthly plans to meet scheduled milestones for product lifecycle activities.
• Support site transfer projects by planning, coordinating, finalizing supply plans, confirming API/excipient availability, conducting risk assessments, transferring technology, and procuring change parts within timelines.
• Track project progress through regular stakeholder meetings, escalate bottlenecks, and evaluate risks for mitigation.
• Manage Regulatory Affairs documents for all ROW markets, monitor submission timelines, and coordinate stakeholder updates for timely approvals.
• Ensure on-time availability of APIs, raw materials, packaging, documentation, and final dispatch for market supply.
• Anticipate and mitigate risks related to API/RM delays, process issues, supply changes, and schedule disruptions; escalate critical risks to senior management.
• Report any non-compliance issues immediately to supervisors.
• Collaborate as part of a team to achieve business objectives, adhering to the “Right First Time” principle.
• Comply with all relevant regulations, including Global Business Ethics and Quality standards.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• Utilize open, honest, two way communication to build trust-based relationships with collegues, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Demonstrate winning behaviors of Individual accountability, Rigor and discipline & continuous improvement throughout.

Job Requirements

• Education
  • Pharm / M.Pharm (MBA or any project management certification is preferable).
• Knowledge, Skills and Abilities
  • Good understing of the manufacturing process development, Scalability and Equipment principles.
  • Documentation and data management related to the technology transfer related to activity.
  • Abitity to cummunicate and collaborate the all cross functional team and meet the deadline as per the goal.
  • Experience in preparation and review of technology transfer document.
  • Well versed with Microsoft Office (Project, Word, Excel and Powerpoint).
  • Experience in PM tools (Planner & BI dashboard).
• Experience
  • 3-5 years experience