Job purpose • Products registration and the life cycle management of existing products (labelling update and maintenance of the product licenses) with timeline set-up. • Short- & long-term registration planning for NCE, LE and new indications including bridging strategy • Management of other regulatory issues

• Planning the best-case scenarios of RA plans for Line Extensions and New indications and sharing the RA strategy with stakeholders through NPI or Launch Excellence Mtg. • 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, TTS 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.

• Bachelor’s degree in pharmacy. • Minimum 6+ years of experience in regulatory including the leadership and delivery of a range of regulatory submissions. • 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.

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