[GSK KOREA] Senior Regulatory Affaist Specialist 채용

외국계 제약기업

글락소 스미스클라인에서

Senior Regulatory Affaist Specialist를 모집 합니다.

Job purpose

• Products registration and the life cycle management of existing products (labelling update and maintenance of the product licenses) with timeline set-up.
• Short- & long-term registration planning for NCE, LE and new indications including bridging strategy
• Management of other regulatory issues

Key Resposibilities

• Planning the best-case scenarios of RA plans for Line Extensions and New indications and sharing the RA strategy with stakeholders through NPI or Launch Excellence Mtg.
• Establishment of short- & long-term detailed registration plan and follow up to meet the expected approval timeline.
• Maintenance of good relationship with regulatory authority and internal stakeholders.
• Timely and appropriate regulatory update of existing products (shelf-life extension, CMC variation, site transfer, GDS update and renewal etc.)
• Management of the existing products (safety issues handling, 3rd party support, TTS update, Registration of Drug ID Mark etc.)
• Communication and cooperation with GRA for regulatory requirements.
• Impact analysis and establishment of strategy according to the amendment of the guidelines.

Requirements

• Bachelor’s degree in pharmacy.
• Minimum 6+ years of experience in regulatory including the leadership and delivery of a range of regulatory submissions.
• Knowledge of regulatory agency guidelines and expectations in the submission process.
• Experience in the regulatory agency review process.
• Proficient English communication to effectively communicate with global and regional colleagues.

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https://jobs.gsk.com/ko-kr/jobs/431841?lang=ko-kr&previousLocale=ko-KR

Senior Regulatory Affaist Specialist 다음에서 Seoul, South Korea | GSK Careers