Sr. Regulatory Affairs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Responsibilities:

Be responsible for the registrations of imported drug. Including but not limited to the good communications with NMPA, CDE and other authority, registration documents preparation, performing the test, documents submissions and follow up of NMPA until get the approval.

Timely documents archiving. Other tasks if needed.

Minimum Qualifications:

Bachelor degree At least 2-3 year’s experience on imported drug registration

Good at written and oral English Preferred

Qualifications:

Medical education background

The experience on all of API, ANDA, IND and other type registration is helpful

Good communications skill