Randstad, as the Johnson & Johnson APAC talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the recruitment agencies in the Randstad group of companies in APAC, and will not be an employee of Johnson & Johnson.

J&J Apac

Regulatory Affairs Specialist

Posted Oct 8, 2021
Project ID: JNJBJP00008045
Location
Singapore , Singapore
Duration
1 year
(Nov 2, 2021 - Nov 1, 2022)
Hours/week
40 hrs/week
Salary range
3000 - 4400 S$/month

 

General Summary

Supports regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for registration submissions in Singapore, Malaysia and rest of ASEAN countries

 

  • Determine and communicate submission and approval requirements.
  • Participate in new product development teams to provide input and expertise on regulatory requirements, determination of global regulatory strategies, review and approval of documentation to support regulatory submissions worldwide.
  • Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval.
  • Monitor and assess impact of changing regulations on submission strategies.
  • Compile, prepare, review and submit regulatory submission to authorities.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned   
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Provide support to requests from post-market clinical studies

 

Required Key Skills / Qualifications:

 

  • Degree holder with 1-3 years of regulatory field experience in Singapore and ASEAN countries
  • Ability to build good relationship with internal and external customers 
  • Good computer skills
  • Strong team spirit, independent, diligent and strong contributor

 

Interested parties, please click on APPLY button.

Alternatively, you can share your CV at joleyn.chin@randstadsourceright.com.sg 

 

EA License: 94C3609 

Reg No: R1440247

 

 

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