Role Summary

Responsibilities:

Lead regulatory projects from initiation to completion, ensuring adherence to project timelines.
Develop comprehensive project plans, including schedules, resource allocation, risk management, and contingency planning.
Supervise project critical teams to ensure high quality deliverables are met in strict timelines.
Monitor project progress, identify potential issues, and implement corrective actions as needed.
Facilitate regular project meetings, providing updates on project status, milestones, and deliverables.
Workflow management: Plan work allocation, assign and direct work to team and act as a subject matter expert for the team. Assure timely movement of project workflow through the process steps in accordance with customer expectations and ICH/FDA regulations and guidelines.
Accomplishes project objectives by planning and evaluating project activities including implementation
Ensure operational objectives by contributing information and recommendations to strategic plans and reviews
Track project deliverables/ SLAs using appropriate tracking tools and provide direction and support to project team
Ensure all projects comply with relevant regulatory requirements and guidelines
Collaborate with cross-functional teams
Facilitate communication and information flow between different departments to achieve project goals
Maintain accurate and organized project documentation, including project plans. Meeting minutes, regulatory submissions, and correspondence.
Prepare detailed reports on project status, metric, and outcomes for senior leadership
Assist management and work closely with other managers to address problem areas, staffing and equipment needs and work scheduling for current and projected project workloads to meet timely deliverables.
Monitor and motivate team to achieve and maintain acceptable levels of performance.
Work closely with the training team and team leaders and identify training requirements of resources and ensure delivery of such trainings.
Participate in inspections and audit interviews and assistance in preparing responses for Corrective and Preventive Action Plan issues as required.

Candidate Profile:

Should hold a master’s in pharmacy / Life Sciences.
Should have 6+ years of experience Project Management with at least 3 years in the Pharma/CRO industry.
Should possess excellent verbal & written English communication skills.
Should be proactive and solution-centric in approach.
Certification in project management will be advantageous.

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Urgent Requirement for Project Managers

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