Senior Regulatory Affairs Associate (CMC)
Taipei, Taiwan 求人ID R0000033633 Category Regulatory / ConsultingAbout this Role
Key Accountabilities:
Submission Coordination:
- Assist in the preparation and coordination of regulatory submissions, including:
- Investigational New Drug (IND) applications
- Investigational Medicinal Product Dossiers (IMPDs)
- Post-approval commitments
- Annual reports
- Responses to regulatory authority questions
- Ensure all submissions are complete, accurate, and compliant with regulatory requirements
- Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
Regulatory Assessment Support:
- Support the team in conducting regulatory assessments of manufacturing changes
- Analyze the potential impact of manufacturing changes on regulatory compliance
- Assist in preparing documentation to support manufacturing change assessments
Regulatory Compliance:
- Stay current with relevant regulations and guidelines
- Contribute to the development and maintenance of standard operating procedures (SOPs) related to regulatory submissions
- Ensure adherence to regulatory requirements throughout the submission process
Cross-functional Collaboration:
- Work closely with various departments, including R&D, Clinical, Manufacturing, and Quality Assurance
- Facilitate effective communication between internal teams and regulatory authorities
- Participate in project team meetings to provide regulatory input and updates
Documentation Management:
- Maintain accurate and up-to-date regulatory documentation
- Assist in the organization and archiving of regulatory submissions and correspondence
- Contribute to the development and maintenance of regulatory databases
Desired Qualities:
- Proactive and self-motivated with a strong work ethic
- Ability to work effectively in a team environment
- Analytical mindset with strong problem-solving skills
- Adaptable to changing priorities and regulatory landscapes
- Commitment to continuous learning and professional development
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