1+ months

Regulatory Affairs Manager

Abbott
北京, Beijing

POSITION:   Regulatory Affairs Manager

DIVISION: Abbott EPD China / Regulatory Affairs

DIRECT REPORTS: None

EDUCATION:

Bachelor degree or above in pharmacy or related science with a pharmaceutical major

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 guildlines.
    • 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).

        ","industry":"Healthcare","title":"Regulatory Affairs Manager
        Job Family: Regulatory Operations
        Division: EPD Established Pharma
        Travel: Not specified
        Medical Surveillance: Not Applicable
        Significant Work Activities: Not Applicable

Categories

Posted: 2019-12-30 Expires: 2020-10-22

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Regulatory Affairs Manager

Abbott
北京, Beijing

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