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BD (Becton, Dickinson and Company) (Sr.) RA Specialist in Seoul, South Korea

Job Description Summary

Job Description

I. OVERVIEW OF THIS POSITION

The Regulatory Affairs Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements in Korea

To support/ conduct all necessary registration activities in compliance with related regulations in worldwide as well as Korea.

II . DUTIES PERFORMED

  1. Regulatory Work
  • To perform/coordinate successful submissions and approval of products including IVD in accordance with IVD Act

  • To review ACR (Assessment Change Requirement) to maintain product licenses inRegulatory compliance

  • To support launching products and Regulatory review of artworks and promotional materials

  • To monitor and analyze new and revised regulation to verify business impact.2. Compliance Work

  • To support launching products Regulatory review of artworks and promotional materials

  • To Review Research Use Only(RUO) reagents in accordance with K-REACH prior to import to Korea

  • To participate in global project

III . REQUIREMENTS

  • University degree

  • Major in Bioscience or Pharmacy (Science background will be preferred)

  • New or Experienced (over 2yr experience in RA is preferred)

  • Good at writing and translation skill in English

  • Communicate clearly and effectively in both Korean and English

  • Good social skills and ability to work in teams

  • Proficiency with standard Windows and Office programs

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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