I contribute to clinical research with expertise and empathy. And I do it
(Junior) Regulatory Affairs Associate
Primary Location: South Korea, Seoul Job ID R0000040145 Category Regulatory Affairs Date Posted 03/26/2026
Overview
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
Import license application(시험용 의료기기 확인서) 및 변경/보고 관리
Tracker 및 데이터베이스 관리 및 팀 회의 조율 등의 Team support 업무
경력자 또는 신입 고려 가능
Chemistry, Biology, Pharmacy 혹은 그 외 유관 전공 학사 이상
오피스/재택 근무 병행
Key Accountabilities:
Project Administration:
- Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.
- Provide basic regulatory affairs services including preparing submission packages Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Document Management:
- Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
- Develop a familiarity with current global regulatory submission standards.
Standard Operating Procedures:
- Develop a familiarity with departmental standard operating procedures and work instructions.
Product Support:
- (Regulatory Affairs only) Under supervision provide support to currently marketed products.
Skills:
Project Execution:
- Works effectively within a team environment.
- Works within broad project guidelines as directed by the project Technical Lead or Project Manager.
- With the guidance of the project Technical Lead or Project Manager, demonstrates the ability to prioritize work to achieve specified project outcomes.
- Capitalizes on opportunities to improve performance and seeks feedback from the project Team Lead and colleagues.
- Applies information provided by the project Team Lead or senior colleagues to complete assigned project activities.
- Produces quality work that meets the expectations of Project Lead and the client.
Relationship Management:
- Completes assigned activities within project scope and objectives under the direction of the Project Lead.
- Identifies project and internal issues to senior colleagues and Project Lead.
- Interacts professionally at all working levels within a client organization and within Parexel.
- Identifies project and/or client needs to the Project Lead.
Parexel-Related Responsibilities:
- Meets established metrics as specified in scorecard on an annual basis.
- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management.
- Defines self-development activities with the support of management to keep current within the industry.
Knowledge and Experience:
- 0-2 years’ experience in an industry-related environment.
Education:
- Bachelor’s Degree in a Scientific or Technical Discipline.
Employee Insights
Why Consultants work at Parexel
