• Products Registration and the life cycle management of existing products (CMC variation, labeling update and maintenance of the product licenses) with timeline set-up. • Short & Long term registration planning for New Chemical Entity(NCE), Line Extension and new indications including bridging strategy • Management of other regulatory issues

• Planning the best-case scenarios of RA plans for NCEs, Line Extensions and New indications and sharing the RA strategy with stakeholders through New Product Introduction(NPI) or Launch Excellence Meeting. • Establishment of short- & long-term detailed registration plan and follow up to meet the expected approval timeline • Maintenance of good relationship with regulatory authority and internal stakeholders. • Timely and appropriate regulatory update of existing products (shelf-life extension, CMC variation, site transfer, GDS update and renewal etc.) • Management of the existing products (safety issues handling, 3rd party support, IQA update, Registration of Drug ID Mark etc.) • Communication and cooperation with GRA for regulatory requirements. • Impact analysis and establishment of strategy according to the amendment of the guidelines

• 3+ years of experience in regulatory including the leadership and delivery of a range of regulatory submissions • Bachelor’s degree in Pharmacy, Biological, Chemical or life-science related • Knowledge of regulatory agency guidelines and expectations in the submission process • Experience in the regulatory agency review process • Proficient English communication to effectively communicate with global and regional colleagues

For more details, please refer to the company website.