Regulatory Affairs Manager

EXPERIENCE:

• Over 5 years working experience in regulatory affairs or R&D for pharmaceuticals including more than 3 years in regulatory affairs.
• Solid registration project management skills;
• Effective problem solving and planning capabilities;
• Good knowledge of NMPA/CDE regulations and guidelines;
• Good working relationship with regulatory authorities;                     
• Good command of oral and written English;                              
• Good communication skill.

• Provide regulatory input to supervisor for decision making on registration filing strategies.
• Manage regulatory submissions process and compliance with regulation and guideline.
• Prepare high quality submission packages for variations, license renewal, annual report, clinical trials and new drug applications within timeline, ensure well implement.
• Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule.
• Develop and maintain tracking system for registration procedure to ensure clear registration status; timely report to the line manager.
• Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient.
• Provide regulatory support to Medical and Marketing team as well as other company personnel.
• Review promotion materials according to the internal SOP.
• Communicate with global/regional RA & local functions to keep the effective registrations, contribute to continuous supply.
• Establish and maintain good working relationships with regulatory authorities (NMPA, CDE, CFDI, institute for drug control, and so on) to guarantee effective product registrations.
• Follow up policy change related to business in terms of RA and share with cross-functions timely.
• Assist supervisor to complete urgent assignments as required in a timely manner.

• Therapeutic areas: Gastroenterology.
• The work includes both life cycle maintenance and new product development
• Product type is mostly small molecule (chemical drug, both innovative and generic ones).