Job Description Summary
Job Description
- Support pharmaceutical and medical device customers for registration of new products and the license maintenance of existing products (including pre-fillable syringes).
- Obtain the documentation and information necessary for registration in the targeted countries
- Collaborate with Global RA Team Members to ensure timely execution of regulatory submissions with business objectives and customer deliverables.
- Answer and fulfill requests and queries originating from regulatory authorities (MFDS, FDA, EU Notified body, Japan PMDA, China NMPA, Malaysia NPRA, etc.)
- Identify applicable regulations and standards, carry out regulatory monitoring, assess the regulatory impact of changes, inform the appropriate internal and external stakeholders.
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Job Requirements:
- Pursue regulatory knowledge and expertise in countries regulatory topics
- Minimum of 4-5 years regulatory or equivalent experience within a device or pharmaceutical company
- Proactive, high performance, result oriented and manage projects with ethical integrity
- Manage multiple projects and deadlines
- Good verbal and writing English skill are preferred
- Proficient in MS Office, including Word, Excel and PowerPoint
※ Veterans and persons with disabilities are given preferential treatment in accordance with relevant laws.
Required Skills
Optional Skills
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Primary Work Location
KOR South Korea - Seoul HQ
Additional Locations
Work Shift