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

Key Resposibilities

• 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.

Requirements

• 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.