Regulatory Affairs Consultant
Taipei, Taipei City, Taiwan 职位编号 R0000033635 类别 Consulting关于这个职位
Submission Planning and Management:
- Plan, manage, and track regulatory submissions in collaboration with the Regulatory Lead
- Prepare high-quality global submissions, either in-house or via CRO
- Ensure timely delivery of compliant submissions to global health authorities
- Develop and maintain submission timelines, identifying and managing critical path activities
Regulatory Operations Expertise:
- Provide regulatory operations expertise to cross-functional submission project teams
- Promote and implement best practices for excellence in planning, preparation, and delivery of regulatory submissions
- Stay current with evolving regulatory requirements and submission standards
Project Team Leadership:
- Act as the primary point of contact for project and/or submission teams for major submissions
- Coordinate and lead submission-related meetings and activities
- Facilitate effective communication between internal teams, CROs, and other external partners involved in submission preparation
Quality Assurance:
- Ensure submissions meet all regulatory requirements and internal quality standards
- Implement and maintain quality control processes for submission documents
- Conduct quality checks on submission components and compiled dossiers
Submission Process Improvement:
- Identify opportunities for process improvement in submission preparation and management
- Contribute to the development and implementation of standard operating procedures (SOPs) related to regulatory submissions
- Participate in initiatives to enhance submission tools and technologies
Cross-functional Collaboration:
- Work closely with various departments, including Regulatory Affairs, Clinical Development, and Medical Writing
- Liaise with CROs and other external partners involved in submission preparation
- Provide guidance and training to team members on submission requirements and processes
Desired Qualities:
- Proactive and self-motivated with a strong work ethic
- Ability to work effectively in a team environment and lead cross-functional groups
- Excellent problem-solving skills and the ability to adapt to changing priorities
- Strong interpersonal skills with the ability to build relationships across various stakeholder groups
- Commitment to continuous learning and staying current with regulatory trends and technologies
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