I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate (CMC)
Primary Location: South Korea, Seoul Job ID R0000033368 Category Regulatory Affairs Date Posted 11/03/2025Overview
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
글로벌 RA 경험자 (Regulatory CMC Biologics for US or EU countries 경험있으신 분, 호주 경험 포함자 우대하나 필수 아님/ Vaccine 경험 우대)
해당 포지션은 호주 (Manufacturing plant) 업무 담당하게 되며, 업무 상 필요에 따라 유연 근무를 하고 있습니다. (풀재택 가능)
업무 상 필요 시 출장 가능자
We are seeking an experienced Senior Associate level of Regulatory CMC to join our team. In this role, you will be responsible for developing CMC strategies and managing regulatory submissions for both early-stage programs and marketed products. The ideal candidate will have extensive experience in authoring and reviewing regulatory submissions, performing regulatory assessments of manufacturing changes, and representing Regulatory CMC in cross-functional teams.
Key Responsibilities:
Regulatory Strategy and Submissions:
- Develop comprehensive CMC strategies for early-stage programs and marketed products
- Author and review regulatory submissions, including:
• Investigational New Drug (IND) applications
• Investigational Medicinal Product Dossiers (IMPDs)
• Post-approval variations/supplements
• Annual reports
• Responses to health authority questions
- Ensure all submissions conform to relevant health authority guidelines and regulations
- Lead submission preparation meetings and coordinate cross-functional input
Regulatory Assessment and Change Management:
- Perform regulatory assessments of manufacturing changes
- Establish data requirements 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 project team meetings
- Lead submission preparation meetings
- Address reviewer comments and manage regulatory correspondence
- Provide regular updates to Management on project status and key milestones
- Mentor junior team members in Regulatory CMC practices
Cross-functional Collaboration:
- Work closely with various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development
- Facilitate effective communication between internal teams and regulatory authorities
- Provide CMC regulatory expertise to support business decisions and product development strategies
Regulatory Intelligence:
- Stay current with evolving CMC regulations, guidelines, and industry best practices
- Contribute to the development and implementation of internal CMC regulatory policies and procedures
- Participate in relevant industry groups and regulatory authority meetings as needed
Qualifications:
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field (Ph.D. preferred)
- Minimum of 8+ years of experience in Regulatory Affairs, with a strong focus on CMC
- Extensive knowledge of global CMC regulatory requirements and submission processes
- Proven track record of successful regulatory submissions and interactions with health authorities
- Strong understanding of pharmaceutical development, manufacturing processes, and quality systems
- Experience with both small molecules and biologics is highly desirable
- Excellent project management skills with the ability to manage multiple projects simultaneously
- Strong analytical and problem-solving skills
- Outstanding written and verbal communication skills
Desired Qualities:
- Strategic thinker with the ability to anticipate and address potential regulatory challenges
- Strong leadership skills with the ability to influence cross-functional teams
- Proactive and self-motivated with a commitment to 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
If you are an experienced Regulatory CMC professional with a passion for developing and implementing effective regulatory strategies, we invite you to apply for this key role in our organization. Join us in ensuring the successful development and commercialization of our products through expert regulatory guidance and leadership.
Employee Insights
Why Consultants work at Parexel
