CMC Regulatory Affairs Specialist
Korea, Republic of, Remote Job ID R0000029799 Category Regulatory / Consulting Date Posted 11/29/2024Overview
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
Parexel FSP is currently looking for a CMC Regulatory Affairs Specialist based in South Korea
Qualifications
- Education: Bachelor's degree or higher
- Experience: At least 5 years of relevant experience
Responsibilities
- Prepare and manage regulatory submissions: Draft and manage documents related to CMC sections in eCTD format
- Plan and oversee regulatory CMC strategies and projects
- Review regulatory documents, including SOPs
- Resolve issues related to manufacturing and quality control
- Solve DP (Drug Product) issues: Out of Specification (OOS), stability, manufacturing
Preferred Qualifications
- Familiarity with GMP, GCP standards, FDA guidelines, and 21 CFR 210 and 211
- Experience in the development of peptide drugs or immune-related treatments
- Experience managing or responding in CRO/CMO/CDMO environments
#LI-REMOTE
Employee Insights
Why Consultants work at Parexel
