The posting
Regulatory & Quality Project Management, Contract, Beach Road
Summary You will lead global regulatory programs and Regulatory Affairs Council (RAC) initiatives within the GSR PMO. Working closely with regional leads, particularly in Asia Pacific, and cross-functional stakeholders, you will drive the planning, execution, and delivery of key regulatory priorities. This role is ideal for a project management professional with regulatory affairs experience and a proven track record of leading complex initiatives across functions, regions, and cultures.
What You Will Work On
Manage regulatory affairs programs and projects in accordance with recognized project management methodologies, ensuring alignment with strategic and regulatory objectives.
Key Responsibilities
- Lead the planning, execution, monitoring, and successful delivery of Global Strategic Regulatory and Regulatory Affairs Council (RAC) initiatives, as assigned.
- Partner with GSR Regional Leads to support regional regulatory priorities, strategic initiatives, and capability-building programs across global markets.
- Coordinate and drive execution of RAC projects that support regulatory intelligence, advocacy, and organizational capability development.
- Develop project charters, business cases, project plans, resource plans, budgets, timelines, risk assessments, and governance structures as required.
- Facilitate collaboration and alignment across divisions and geographic regions to ensure effective execution and engagement.
- Manage cross-divisional and cross-functional projects involving Regulatory Affairs, Quality, Government Affairs, and other stakeholders.
- Monitor progress, milestones, budgets, dependencies, and deliverables, providing regular reporting and updates to leadership and governance teams.
- Identify and proactively manage project risks, issues, and resource constraints to ensure timely resolution and successful outcomes.
- Develop and implement PMO processes, governance frameworks, performance metrics, and reporting tools that enhance project visibility and execution effectiveness.
- Support development and implementation of regulatory processes, operating models, SOPs, guidance documents, and best practices.
- Drive continuous improvement initiatives to enhance operational efficiency, stakeholder engagement related to project management maturity.
Competencies & Requirements
- Bachelor's degree in a relevant discipline.
- Minimum 7 years of experience within a regulated industry, including 3-5 years of project or program management experience.
- Lead and manage global regulatory programs, strategic initiatives, and cross-functional projects, ensuring successful planning, execution, governance, and delivery across multiple regions and stakeholder groups.
- Drive collaboration among Regulatory Affairs, Quality, Government Affairs, and business teams to advance regulatory priorities, organizational capabilities, and strategic objectives.
- Develop and implement project plans, governance frameworks, SOPs, operational processes, business cases, budgets, resource plans, risk assessments, and performance metrics to support program success.
- Provide expertise in Regulatory Affairs and Quality, including global regulatory frameworks, health authority engagement, regulatory intelligence, and compliance requirements within regulated industries.
- Lead complex cross-functional and cross-divisional initiatives across healthcare, medical devices, diagnostics, nutrition, pharmaceuticals, or other regulated sectors.
- Manage projects involving multiple stakeholders, organizations, geographic regions, and cultures, while facilitating alignment and effective decision-making.
- Monitor project progress, budgets, risks, dependencies, and deliverables to ensure projects are completed on time and achieve measurable business outcomes.
- Translate strategic objectives into actionable plans, drive continuous improvement initiatives, and strengthen project management maturity and operational excellence.
- Support regional and global regulatory initiatives, including stakeholder engagement across international markets and diverse time zones.
- Conduct regulatory analysis, gap assessments, and evaluations of regulatory requirements, including support for regional regulatory environments such as China NMPA where applicable.
- Contribute to Post-Market Surveillance (PMS), Quality Assurance, and broader regulatory programs, including the development of regulatory tools, comparison analyses, and supporting documentation.
- Apply analytical, problem-solving, budgeting, resource planning, risk management, communication, presentation, and stakeholder management skills to deliver business results.
- Demonstrate the ability to work effectively in highly matrixed global organizations, navigate ambiguity, manage competing priorities, and maintain a high standard of operational excellence.
- Data analysis skills a plus.
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Abelene Kang | R2089914 | EA License No: 02C3423 Reg No: 199505951H
