Associate Specialist, Regulatory Affairs

New MA applications for assigned products  

• Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing, external affairs departments, outcomes research on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Tracks process on products registration and major new indications. 

Maintenance of licenses for assigned products  

• Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations, renewals and RMPs, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes. 

Compliance 

• Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs. 

• Ensures that regulatory databases and systems are kept updated and complete. 

• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.  

• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.  

• Adequately support other functions as applicable to enable compliance in areas related to regulatory. 

Editing and labelling 

• In connection with submission of MA applications and post-approval submissions assists in preparation, translation and QRD check  and performs quality assurance including linguistic check of these documents. 

Artwork development 

• Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.  

• The incumbent proofreads packaging components and is responsible for maintaining an updated file on packaging components, as applicable.  

Additional location(s) Compensation Information:

Current Employees apply HERE

Current Contingent Workers apply HERE

• 의약품 허가 및 변경허가 업무 지원

• 제품 허가 유지관리 (Lifecycle Management)

• Regulatory Compliance 및 문서 관리

• 라벨링 및 Artwork 검토·관리
• 식약처 및 유관부서와의 협업지원

이 포지션은 1년 계약직입니다.