[글락소 스미스클라인] RA Specialist 6개월 계약직 채용

외국계 제약기업 클락소스미스클라인 에서 RA Specialist 6개월 계약직을 채용 합니다.

계약조건: Full-Time (6 months contract - 상황에 따라 연장 가능)

신입 지원 가능

 

Key Responsibilities:

The Regulatory Specialist will play a key role in submissions to ensure the successful delivery of an overall regulatory plan. The specialist will lead interactions with the LOC’s and central teams, ensuring regulatory plans are able to meet the business goals. The role will be exposed to a variety of regulatory activities and, in time, will be given the opportunity to take on more strategic regulatory responsibilities as the role grows alongside personal capability and potential.

 

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Responsibility for the leadership of, preparation, and review of day to day regulatory submissions with full accountability for delivery
• Accountability for larger submissions as part of an overall project plan i.e. initial submissions and responses to questions
• Working with Global Regulatory Lead/Regional representative/Team Manager, to develop a regulatory strategy
• Ensuring quality of both own and teamwork and compliance with regulatory guidelines and process within the required timelines
• Liaising with Regulatory Agencies to resolve straightforward issues in relation to their accountabilities
• Implementation of the submission strategy
• Responsible for the maintenance activities associated with an Approved product / Investigational products

Requirements

• Bachelor’s Degree in pharmacy or biological or chemical science
• Preferably in 1+ year of relevant experience in regulatory affairs including the leadership and delivery of a range of regulatory submissions
• Knowledge of regulatory agency guidelines and expectations in the submission process
• Experience of the regulatory agency review process

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RA Specialist (6M contract) 다음에서 Seoul, South Korea | GSK Korea