Job Summary:
This position is based at Lotus Taipei office and involves working closely with the local RA teams to manage the registration for in-licensing products. The role is accountable for RA experiences in new submissions and life-cycle management across both Asia and Southeast Asia. English communicative skills in spoken and writing clearly, concisely, and effectively are essential. This role offers exposure to an international RA environment and facilitates the development of expertise in regulatory affairs and project management.
1. Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through national procedures in the APAC region.
2. Coordinating the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects.
3. Providing support for samples preparation and dispatch, when necessary.
4. Ensuring all the additional processes relating national submissions (pre-reviews, DMF, PMF and GMP accreditation etc.) are submitted on time and those submissions/approval processes do not delay drug registration.
5. Communicating with third parties in order to expedite submissions and ensure regulatory compliance.
6. Ensuring all responses to authorities’ requests are correct, complete and timely submitted, including the responses to LoDs for the allocated projects as well as the ones related to PI for all the ongoing procedures.
7. Ensuring 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.
8. Controlling costs and ensure proper internal evaluation and approval for each cost before it is being generated.
9. Providing support for documents and samples preparation for tenders and legal activities related to patents.
10. Coordinating the arrangements for inspections requested by the local authorities.
11. Maintaining the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions.
12. Ensuring that the internal regulatory database applicable trackers and SharePoint locations are kept up-to-date.
