Regulatory Affairs Specialist

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. Korea, Republic of
South Korea
Posting date: 12 Jun 2020
29251

A leading medical company in healthcare is seeking an enthusiastic Regulatory Affairs Specialist to be part of their team in South Korea. This is the ideal opportunity for a bright and dynamic individual to join an innovative team.

Job Description

  • Obtain registration of new products and be compliant and effective with all product safety activities in Korea
  • Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy.
  • Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
  • Prepare, submit and support clinical trial applications including all related safety activities.
  • Maintain current knowledge of relevant regulations, including proposed and final regulations and provides regulatory affairs related information to other divisions and department
  • Assist regulatory country lead to provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications.
  • Assist regulatory country lead to develop and maintain standard operating procedures or local working practices.

Qualification Required

  • Experience in working with MS office in a Windows environment
  • Negotiating and interpersonal skills
  • Fluency in written and spoken English

To Apply

Please contact Cherry Medrano on c.medrano@proclinical.com.sg or upload your CV on our website - www.proclinical.com/send-cv

#Commercial

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