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Regulatory Affairs Manager - Medical

One Arrow Consulting Asia Limited

  • Company Industries:Human Resources Management/Consultancy

Job Information

  • Post Date:2018-07-04
  • Career Level:Middle
  • Location:Not Specified
  • Salary:Salary provided
  • Employment Type:Full Time, Permanent
  • Job Function:Legal & Compliance  Specialist  Quality Assurance, Control & Testing / ISO  

Job Description

Lead and manage the critical regulatory tasks – i.e. registration strategy, dossier compilation, data and documentation review, submission execution, evaluation review etc.
Demonstrate skills and knowledge in areas such as, but not limited to: strategy development, risk assessment and management; monitoring and communicating change in the regulatory environment as well as global communication; staff and vendor development and management.
 
 
Regulatory Affairs
  • Work with local RA personnel to ensure maintenance of existing registrations and timely registration of new products.
  • Establishes a credible surveillance system for maintaining knowledge of the existing and RA, Health and Safety, and QA requirements.
  • Design and implement programs, policies, and practices to ensure that all divisions are in compliance with federal, state, and local regulatory requirements.
  • Implement and manage any locally required product labeling in partnership with manufacturing divisions, ensuring all products in the relevant countries/region comply with local and international regulatory and compliance requirements.
  • Assess changes in the Regulatory environment, and the potential impact on the business.
  • Use various forms of communication to ensure the regulatory aspects of the business are successfully communicated to all staff.
  • Act a central communication point with manufacturers in regards to registration processes and issues.
  • Prepare compliance reports to ensure management are kept informed of progress, initiatives and risks.
  • Maintain a register for the renewal of product registration.
  • Anticipate change in future business needs and market trends and implement procedures to manage and grow the business.
  • Have robust and up to date knowledge of Regulatory requirements throughout the region
Education
  • Basic Degree in Life Sciences specialties, e.g.: Pharmacy, Medicine, Biological Sciences
  • 7+ years of regulatory experience in pharma and regulated industry 
  • Basic knowledge in drug development, pharmacovigilance, QA would be advantageous
  • Experience at a management level within a multi-national corporation preferred
  • Experience working with cross cultural groups preferred
  • Fluent in written, reading, spoken and listening English. 2nd Asian language advantageous
  • Excellent attention to detail
  • Strong excel and systems skills
  • Willing to work flexibly as role demands

 

We offer an attractive remuneration package, generous fringe benefits as well as excellent opportunities for career advancement. Please send your application letter to

Jefferson.lim @onearw.com

(All information received will be kept in strict confidence and only for recruitment purpose. Applicants who are not invited for interview within 6 weeks may consider their applications unsuccessful.)

 

Company Info

One Arrow Consulting Group offers recruitment solutions within specific industries across the Asia region. We pride ourselves in Specialism. To effectively and efficiently serve our clients, our core team members are either industry recruitment specialists or actual industry specialists.

This business model allows us to truly understand the needs of our clients to provide talent consulting services at the highest quality. We have physical presence in Hong Kong & Singapore, and servicing all of Greater China & South East Asia.

Currently we service the following Industries: Insurance, Medical, and Corporate Services

For more information, please visit our website at www.onearw.com.

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