Sr. Regulatory Executive

Major Responsibilities：

• Establish, maintain and develop good relationships with the State Food & Drug Administration (SFDA), to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).
• Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and GSK requirements.
• Ensure that Regulatory Affairs International (InRA) is kept fully informed on the current regulatory status of all assigned products.
• Ensure that Import product labeling and PI is consistent with SDA guidelines and requirements.
• Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to SFDA.
• Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with SDA and GSK requirements.
• Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.
• As required co-ordinate activities with InRA.
• Provide professional RA input for cross function projects

Requirement：

• Possesses a Bachelor degree in microbiopharmaceutics or relevant speciality .
• 3 years of regulatory work.
• Good verbal and written communication skills.
• Expert knowledge of regulatory policies and registration processes in China.
• Excellent inter-personal skills.
• Extensive and close contacts with KOLs.
• Independence in judgement..
• Bachelor degree in medicine, bio-pharm products.
• Proven ability to communicate (written/oral) in English.
• Good verbal and written communication skills.
• Proven competency with the following computer software: Word, Powerpoint, Microsoft Project and Excel.
• Medical knowledge: Preventive medicine, epidemiology and immunology expertise.
• A comprehensive understanding of the Chinese registration requirements and regulations.
• Good understanding of the structure, functions and operating procedures of the State Food & Drug Administration (SFDA).
• Proven understanding of clinical research guidelines including GCP, GMP, GLP and Chinese GCP.
• Knowledge of the relevant technical manufacturing operations including operations management, GMP and QA/QC.
• Possesses an established record of preparing and achieving product registrations.