Regulatory Affairs Specialist
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.
- 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.
- Experience in working with MS office in a Windows environment
- Negotiating and interpersonal skills
- Fluency in written and spoken English