Regulatory Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
EXPERIENCE:
- Over 5 years working experience in regulatory affairs for pharmaceuticals including more than 3 years in the project management post;
- Solid registration project management skills;
- Effective problem solving and planning capabilities;
- Good knowledge of NMPA regulations and guidelines;
- Good working relationship with regulatory authorities;
- Good command of oral and written English;
- Good communication skill.
RESPONSIBILITIES:
- Provide regulatory input to supervisor for decision making on registration filing strategies.
- Set up product registration timeline and ensure well implement.
- Prepare and validate registration dossier to ensure fully meet Chinese regulations and guidelines.
- 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 area RA & local functions to keep the effective registrations and ensure no delay for the market supply due to IDL renewal.
- 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.
MORE SPECIFIC INTRODUCTION
- Therapeutic areas: Women Health Gastroenterology Cardiovascular.
- The work includes both life cycle maintenance and new product development
- Product type is mostly small molecule (chemical drug both innovative and generic ones).
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
China > Shanghai : 388 W. Nanjing Road Ciros Plaza
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
