RA&PA Specialist, PS
BD (Becton, Dickinson and Company)
**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.
**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
.
**Primary Work Location**
KOR South Korea - Seoul HQ
**Additional Locations**
**Work Shift**
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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