Regulatory Officer

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

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

Qualifications

• 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

Additional Information

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.