Regulatory Affairs Consultant
Primary Location: Taiwan, Taipei 求人ID R0000033635 Category Regulatory / ConsultingAbout this Role
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
JOBS FOR YOU
There is no jobs to view
現在、閲覧できる保存されたポジションはありません。
このサイトで保存されたポジションを表示できるようにするために、クッキーの受け入れを有効にしてください。このページにアクセスすると、保存されたポジションを確認することができます。
More Than A Job
