Senior Project Manager, Regulatory Affairs
New
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 10–15+ years
- Required Skills
- Project ManagementBudgetingRisk ManagementStakeholder management
Requirements
- 10–15+ years of overall experience, including significant exposure to Regulatory Affairs and project/program management
- Strong background in Regulatory Affairs within pharmaceutical or life sciences environments
- Proven experience managing large-scale, cross-functional projects in APAC or global settings
- Strong understanding of regulatory frameworks, compliance processes, and lifecycle management
- PMP certification preferred or equivalent project management expertise
- Demonstrated ability in stakeholder management, client engagement, and executive communication
- Strong analytical, problem-solving, and decision-making skills in high-pressure environments
- Experience in budgeting, forecasting, governance, and operational performance tracking
- Excellent leadership, team management, and collaboration skills across distributed teams
Responsibilities
- Lead the delivery of cross-functional projects in Regulatory Affairs, ensuring scope, timelines, quality, and compliance standards are consistently met
- Serve as the primary client contact for project status, risks, escalations, and performance reporting
- Establish and maintain project governance frameworks, including risk/issue logs, change control, and audit-ready documentation
- Oversee project budgets, forecasting, variance tracking, and change order management
- Manage resource allocation, staffing plans, onboarding processes, and team performance coordination
- Monitor KPIs and contractual performance metrics, ensuring continuous improvement and operational efficiency
- Drive escalation management, root-cause analysis, and corrective/preventive actions across delivery streams
- Collaborate with regulatory, operations, and functional teams to ensure seamless execution across APAC markets
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