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Prepare submissions for the new product registration (GMP, DMF, Pharmaceutical Equivalence Test etc.)
Initiate, track and facilitate new product registrations and achieve on-time approvals ( from sending POF to approval)
Ensure maintenance of registered product license (Variations, Re-evaluation, Annual report etc.)
Monitor regulatory environment changes, and provide impact analysis plus action plans to ensure compliance
Assist Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations
Assists Regulatory Affairs Manager for coordinating regulatory activities between Divisions/Business Units and have timely communications with BU RA, Regional RA
Timely update and regularly check global RA database, RegTrack and Sharepoint
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Experience & Academics
Have experience in RA at least 3~5 years
University graduated / Majored in Pharmacy.
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