The Manager, Regulatory Affairs is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products.
This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.
Drives the development and implementation of the regional regulatory strategy that optimize development, registration, and lifecycle management of new and marketed products.
Expedites commercialization of new indications and line extension by providing regional regulatory inputs.

Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
5-10 years of overall experience in relevant pharmaceutical industry and preferably with regulatory experience.
Regional experience preferred.
Hands on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred.
Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and/or Registration dossiers) also preferred.
Excellent verbal and written communication skills – proficiency in written and oral English and [Mandarin/Asian (Asia) languages is preferred.]

Manager, APAC, Regulatory Affairs, Immunology

Key skills