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).