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Coordinator, Regulatory Affairs

DKSH Hong Kong Limited

  • Company Industries:Others

Job Information

  • Post Date:2024-05-12
  • Location:Wong Chuk Hang
  • Employment Type:Full time
  • Others:Regulatory Affairs
    Product Registration and Life Cycle
    Product Compliance
  • Job Function:Pharmaceuticals  Medical  Devices  

Job Description

Job Responsibilities:

Product Compliance Responsibilities:
 

  • Take ownership of the process of inbound goods compliance check.
  • Coordinate the release of products following compliance checks.
  • Assist in documentation review (e.g. specifications for starting materials / repackaging)
  • Coordinate and collaborate with internal stakeholders.
  • Adhere to relevant Standard Operating Procedures (SOPs) and complete SOPs training within given timelines.

 

Product Registration and Life Cycle Responsibilities:

  • Coordinate and collaborate with clients and internal commercial teams on regulatory submissions and product variation management.
  • Ensure product registration records are kept up to date and comply with regulatory requirements, including post-approval changes and renewals.
  • Collect and maintain regulatory documents.

 

Day to Day Responsibilities:

  • Maintain a database with information on the registration status of the product portfolio.
  • Continuously enhance knowledge regarding regulatory submissions and requirements.
  • Assist regulatory staff with submissions to regulatory authorities.
  • Perform other assigned duties.
  • Promptly report any problems to supervisor.

 

Job Requirements:

  • University degree in a science or medical-related field
  • Regulatory affairs experience in pharmaceutical industry is preferred
  • Proficient in both English and Chinese
  • Possess working knowledge of MS Office
  • Excellent communication and interpersonal skills
  • Well-organized, detail-oriented, and diligent
  • Proactive and capable of working independently

 

Work location: Tsing Yi  / Wong Chuk Hang

We offer 5-day work week, performance bonus and attractive benefits including medical insurance. Please apply with full particulars, contact number and current/ expected salary to Human Resources Department, DKSH Hong Kong Limited, 23rd Floor, Tower A, Southmark, 11 Yip Hing Street, Wong Chuk Hang, Hong Kong or click 'Quick Apply'.

All personal data collected will be used for recruitment purpose only.  Candidates will be contacted within 2 weeks if the background and experience are closely relevant to the job requirement.

Why It’s Great to Work at DKSH
At DKSH, we are driven by a purpose that goes beyond the ordinary: enriching people's lives. Through the products and services we provide, DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference! https://www.dksh.com/careers

Company Info

DKSH Hong Kong Limited

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