Regulatory Affairs (RA) Specialist
Job
Purpose
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Ensure
timely submission for regulatory approval of new & marketed VC (Vision
Care) products and up-to-date of registration file of Alcon Korea.
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Fulfil
all regulatory compliance activities and responsibilities as required
including GMP
Responsibilities
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To
prepare and manage registration filings including new submission, license
maintenance, renewal and GMP certification across Alcon Korea product
lifecycles
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To
communicate with global GRA/Manufacturer. R&D for filing, submission
& requirements
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To
monitor and communicate all regulatory filings status and respond to internal
and external queries, or other needs
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To
ensure timely regulatory filings submissions and approvals
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To
ensure regulatory compliance to secure business continuity – labeling
management, licenses maintenance, RIAR (Regulatory Impact Assessment Report),
GMP management, licenses renewal, promotional material approval, etc.
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To
contribute to establishment of regulatory database
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To
comply with all legal, regulatory, and ethical business requirements in
executing the assigned roles and responsibilities as defined in the local
regulation and the Corporate procedure
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