Regulatory Affairs Manager

Major Responsibilities：

• Regulatory policy and consulting
• Comment based on the regulations and notices as well as personnel information from SFDA, CDE, NIFDC websites twice a week;
• Maintain the updated knowledge of guidelines especially for those have been enforced;
• Advice on RA consulting from BD team;
• Regulatory operation
• Draft submission plan for all submission assigned;
• Contact with HQ and or partner to obtain the necessary resources and sample as well as materials for submission;
• Complete CTA/IDL as well as maintenance submission dossier preparation, submit it and follow up through whole SFDA and CDE review and approval procedures and interact with the review authorities to answer question and provide supplementary submission when need;
• Interact with NIFDC or other drug quality authority for QC check and specification confirmation;
• Organizing CDE panel meeting and prepare related meeting documents accordingly;
• Complete study drug importation Custom Pass application to local drug authority for both NIFDC testing and clinical trial;
• Generate the ICF and Investigator Package review and approval plan and oversee the conduct;
• May supervise junior RA staff;
• Other relate to RA assigned by the dept. head.

Requirement：

• Master degree or above preferably in pharmacy.
• More than 6 years RA experience.
• Proficiency in Basic computer usage.
• Good communication skill.
• Fluent in English writing and speaking ability