Director, Regulatory Affairs Stratregy And Planning

Singapore, Singapore

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Primary Responsibilities:

- Lead cross-functional teams for regulatory submissions in the region, managing interactions and collaborations with senior leaders.
- Maintain comprehensive knowledge of submission planning activities within the assigned portfolio.
- Develop and implement regulatory program strategies in the Asia Pacific markets to ensure efficient submission planning and execution.
- Coordinate and streamline communication to address urgent matters and maintain balanced workloads across the region.
- Oversee regulatory projects from authorization to delivery for country regulatory affairs teams and Health Authorities, focusing on regulatory operations.
- Develop and maintain regulatory submission plans for key projects/products, tracking project milestones.
- Participate in or lead cross-functional forums and meetings.
- Collaborate closely on assigned products/projects.
- Ensure effective oversight of outsourced activities, maintaining quality, compliance, and performance against key criteria.
People Management Responsibilities:
- Supervise the Regional Regulatory team
- Mentor and coach team members on project management, publishing, and company processes related to high-performing teams, drug development, and regulatory practices.

Qualifications and Skills: To be successful in this role, you will have:

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