法規事務專員Regulatory Affairs Specialist

We are seeking a detail-oriented Regulatory Affairs Specialist to support pharmaceutical regulatory activities and product registrations in different countries. The role will focus on regulatory document preparation and compilation, coordination with internal teams and overseas partners, and research of country-specific regulatory requirements.
•Support preparation, compilation, and maintenance of regulatory submission documents.
•Coordinate with global partners and internal teams to collect documents and fulfill country-specific registration requirements.
•Review and organize CTD documents and identify information or documents needed for submissions.
•Support preparation of responses and documents for regulatory authority requests.
•Research regulatory pathways, submission requirements, and relevant regulatory updates for countries of interest.
•Maintain regulatory documents, submission records, and version control.
•Work with Clinical, Nonclinical, CMC, BD, and other teams to support regulatory submissions and routine RA activities.