Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
21-08-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
JOB DESCRIPTION:
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).
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 > Beijing : Canway Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
