Regulatory Officer

Benefits

Additional Information

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. Office-based in Shanghai/Beijing Your role: Liaises with project teams to procure documents necessary for regulatory and ethics committee submissions. Prepares regulatory and ethics committee submission dossiers, including applications for import and export licenses. Reviews translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams). Tracks regulatory project documentation flow and progress reporting. Tracks changes/amendments to legislative acts pertaining to clinical trials in PSI countries and timely notifies all parties involved. Under supervision maintains a database of regulatory requirements Bachelor's or above Degree in Medicine, Pharmacy and relevant Life Sciences major. At least 5 years experience with clinical trial submissions in China Full working proficiency in English and Mandarin Proficiency in MS Office applications Detail-oriented Ability to learn, plan and work in a dynamic team environment Communication, collaboration, and problem-solving skills If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Psicro? Share your experience