Regulatory Affairs Consultant
Primary Location: Taiwan, Remote Job ID R0000033634 Category Consulting Date Posted 07/02/2025Overview
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
Strategic Leadership:
- Provide strategic direction and oversight for CMC aspects of late-stage and marketed products
- Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives
- Develop comprehensive CMC strategies to support product development, registration, and lifecycle management
Regulatory Strategy and Submissions:
- Develop and oversee CMC strategies for complex regulatory submissions, including:
- Investigational New Drug (IND) applications
- Investigational Medicinal Product Dossiers (IMPDs)
- Biologics License Applications (BLAs)
- Marketing Authorization Applications (MAAs)
- Post-approval variations/supplements
- Responses to health authority questions
- Author and review high-level regulatory submissions
- Ensure all submissions conform to relevant health authority guidelines and regulations
- Lead submission preparation meetings and coordinate cross-functional input
Health Authority Interactions:
- Lead regulatory CMC discussions and interactions with Health Authorities
- Represent the company in high-level meetings with regulatory agencies
- Develop strategies for addressing complex regulatory questions and issues
- Build and maintain positive relationships with key regulatory stakeholders
Regulatory Assessment and Change Management:
- Oversee regulatory assessments of manufacturing changes
- Establish data requirements and strategies for regulatory submissions related to manufacturing changes
- Provide expert guidance on CMC-related regulatory implications of proposed changes
Project Management and Leadership:
- Represent Regulatory CMC at high-level project team meetings and governance committees
- Lead critical submission preparation meetings and regulatory strategy discussions
- Address complex reviewer comments and manage sensitive regulatory correspondence
- Provide regular updates to senior management on project status, risks, and key milestones
- Mentor and develop team members in Regulatory CMC practices and strategic thinking
Cross-functional Collaboration:
- Work closely with senior leaders across various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development
- Facilitate effective communication between internal teams, external partners, and regulatory authorities
- Provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management
Regulatory Intelligence and Innovation:
- Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices
- Drive the development and implementation of innovative CMC regulatory strategies
- Participate in and potentially lead relevant industry groups and regulatory authority initiatives
Desired Qualities:
- Visionary leader with the ability to anticipate and navigate complex regulatory challenges
- Strategic thinker with a talent for innovative problem-solving and risk management
- Strong leadership skills with the ability to influence cross-functional teams and senior management
- Proactive and self-motivated with a commitment to regulatory excellence
- Adaptable to changing priorities and evolving regulatory landscapes
- Excellent interpersonal skills with the ability to build strong relationships with internal and external stakeholders
- Detail-oriented with a focus on quality and accuracy, while maintaining a big-picture perspective
- Ability to thrive in a fast-paced environment and manage competing priorities
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