Regulatory Affairs Director

3 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

As a **Regulatory Affairs Director **, you have the opportunity to make a significant impact on the organization and its stakeholders. By navigating the regulatory landscape, developing strategies, and effectively leading cross-functional teams, you inspire collaboration, innovation, and a shared sense of purpose. Your role as a Regulatory Affairs Director offers the chance to inspire and guide others towards achieving regulatory excellence, shaping the future of the organization.

**Main Responsibilities**:

- Leading cross-functional teams for regulatory submissions in the region, managing interactions and collaborations with senior leaders.
- Maintaining a comprehensive knowledge of submission planning activities within the assigned portfolio.
- Developing and implementing regulatory program strategies in the Asia Pacific markets for efficient submission planning and execution.
- Coordinating and streamlining communication to address urgent matters and maintain balanced workloads across the region.
- Overseeing regulatory projects from authorization to delivery for country regulatory affairs teams and Health Authorities, with a focus on regulatory operations.
- Developing and maintaining regulatory submission plans for key projects/products, diligently tracking project milestones.
- Actively participating in or leading cross-functional forums and meetings.
- Collaborating closely on assigned products/projects, ensuring effective coordination and integration.
- Providing effective oversight of outsourced activities, ensuring quality, compliance, and performance against key criteria.

**Criteria**:

- **Education and Experience**: A bachelor's degree in a Life Science-related discipline with 10-12 years of experience in Regulatory Affairs, with at least 3 - 5 years in a similar leadership capacity.
- **Regulatory Expertise**: In-depth understanding of regulatory submission standards, procedures, and the drug development landscape across the APAC region.
- **Strong Planning and Delivery Skills**: Capability to oversee complex planning, tracking, and delivery of regulatory content, ensuring alignment with regulatory strategy, compliance, and customer needs.
- **Leadership and Collaboration**: Demonstrated experience in leading cross-functional teams to ensure high-quality and timely submissions, fostering collaboration and effective communication.
- **Adaptability and Innovatio **n: Ability to navigate unfamiliar situations, embracing ambiguity and providing clear direction, while maintaining a service delivery mindset driven by innovation and continuous process improvements.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

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