(Sr)Regulatory Affairs Manager

DEPARTMENT FUNCTION/OBJECTIVES

The Regulatory Affairs Department obtains and maintains marketing approvals of responsible Abbvie

products in Taiwan. It ensures full local regulatory and company compliance, and provides regulatory

expertise to support clinical research, product launches, business development so as to assist achieving business growth and full compliance with legal requirements for pharmacovigilance regarding regulatory affairs relevant responsibilities.

 

PRIMARY FUNCTION/OBJECTIVE

The position is to handle preparation of regulatory submissions in order to obtain and maintain marketing approvals of company products, to provide advice on regulatory matters to staff and customers and design RA strategy and lead cross functional meeting.

RESPONSIBILITIES

• Independently manage registration of new products and variations to marketed prod...