This position is located at Lotus Taipei office and work closely with global RA team mainly take care in-licensing projects. The ideal candidate has strong RA experience with Asia or South East Asia region new submission and life-cycle production management. Good English communication skill is import for this role both writing and speaking in order to clarify the needs and requirement from Local RA team and suppliers. This role allows you to exposure to international RA environment and equip project management skill.
• Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through national procedures in the APAC region.
• Coordinate the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects.
• Provide support for samples preparation and dispatch, when necessary. • Creation and update of the Product Information (PI), irrespective of the source of
• Collaboration with the Pharmacovigilance Department for streamlining the processes with impact on PI and safety variations.
• Communicate with third parties in order to expedite submissions and ensure regulatory compliance.
• Ensure that all the additional processes related to national submissions (pre-reviews, DMF, PMF, GMP accreditation etc.) are submitted on time and that their submission/approval process does not delay the application.
• Ensure that accurate and complete information is timely provided to other departments/third parties and inform the relevant functions on the status and progress of the assigned projects in order to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur.
• Control costs and ensure proper internal evaluation and approval for each cost before it is being generated.
• Provide support for documents and samples preparation for tenders and legal activities related to patents.
• Coordinate the arrangements for inspections required by the local authorities.
• Maintain the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions. • Ensure that the internal regulatory database applicable trackers and SharePoint locations are kept up-to-date.