담당업무

l   Compile documentation and oversee regulatory submission activities within defined time schedules.

l   Plan and manage regulatory strategies for prospective new product, variation and renewal including regulatory time frame.

l   Time management for product registration.

l   Respond to regulatory authority deficiency questions with strict deadlines.

l   Keeping up-to-date with changes in regulatory legislation and guidelines.

l   Liaising and negotiating with regulatory authorities.

l   Providing advice about regulations.

l   Ensuring compliance with regulations.

l   Communicating with global & regional RA team and plants.

l   Collaborate with global regulatory team to develop global regulatory strategy.

l   Present regulatory project updates and regulation or guidance changes to Regional/Global Regulatory Affairs and Senior Leadership.

l   Perform gap analysis of proposed and implemented regulatory guidance documents and regulations and propose solutions.

l   Join annual meeting in AP regional office.

l   Planning, undertaking regulatory inspections.

l   Provide guidance and coaching for areas of responsibility to lower level team members.

[자격요건]

l  경력: 12년 이상 15년 이내 

-       약사

-       영어 업무 가능자