職位描述
職責描述：
Report to the head of RA/CA, to ensure the products are registered in alignment and compliance with applicable regulations, standards and business ives.
Act as the Regulatory partner for the BU he/she is responsible for. Develops and implements strategies for timely submission and approval of product.
Ensure accurate and optimal presentation of regulatory submissions, and keep a consistent achievement of registration projects in expected schedule.
Give guidance and supervise team members’ product registration dossiers to provide regulatory guidance and solve the difficulties.
Monitor regulations and standards developments affecting the products he/she is responsible for, update the regulation and guideline to BU on time, and translate regulatory requirements into practical, workable plans.
Represent the company and interact with regulatory authorities, industry associations, standards bodies as appropriate.
Manage the regulatory review of labeling for products that are under his/her responsibilities.
企業介紹
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.
