Manager, Regulatory Affairs

Posted:
6/11/2025, 6:25:36 PM

Location(s):
Bei Jing Shi, China

Experience Level(s):
Senior

Field(s):
Business & Strategy ⋅ Legal & Compliance

Job Description

Job Responsibilities:

Manage registered products and support product registration projects within the team aligned timeline.

  • Communicate with international RA
  • Provide RA input on the strategic planning for all responsible products
  • Prepare registration dossiers and questions following related regulations and procedures
  • Make good relationship with officials
  • Make good relationship with experts
  • Organize the registration evaluation meeting
  • Coordinate Q.C. re-confirmation test with institute for drug control
  • Obtain final registration permits

Job Requirements:

  • Bachelor and above in medicine, pharmacy or related disciplines
  • Minimum 6 years working experience in pharmaceutical industry
  • Over 5 years’ experience in registration field
  • Proficiency in the use of EXCEL, POWERPOINT and WORD
  • Good command in English, both in written and spoken
  • Proactive and teamwork spirits

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Audits Compliance, Cytogenetics, Cytology, Cytopathology, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Healthcare Project Management, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

 Preferred Skills:

Job Posting End Date:

12/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.