Senior Regulatory Affairs Associate (CMC)
Taipei, Taiwan Job ID R0000033633 Category Consulting Date Posted 07/18/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About 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
Employee Insights
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