Regulatory Affairs Manager (Regional)

Location Tuas, Singapore
Job reference RN SEL _1565857127
Salary Negotiable
Consultant name Selina Lim Siew Yen
Consultant email
Consultant contact no. 65515298
EA License No. 02C3423
Consultant Registration No. R1333126

Job Description:

  • Accountable for creating post approval submissions for Drug Products for country acceptability in terms of content, according to local regulations and requirements for assigned markets
  • Ensure Dossiers (electronic,paper copy, HA portal) are produced, dispatched to assigned markets according to their defined filing plan and submission ready
  • Ensure processess transparency and excellence in execution of regulatory strategies
  • Collaboration across the regulatory organization with stakeholders (such as Product Strategist and in-market Strategists) to deliver efficiencies in Regulatory submissions and processes
  • Ensure submission planning and forecasting tool is utilized to update timeline when required, communicate changes to relevant partners
  • Capable of authoring some local submission components in relevant databases ensuring submission package reviewed against local CMC requirements for consistency and completeness


  • Minimum 5 years of regulatory affairs experience in pharma and regulated industry
  • A good balance of Regulatory and Business acumen
  • Fair knowledge and understanding of drug/healthcare regulations and ability to apply them effectively
  • Attention to detail and analytical skills

Interested Applicants

Kindly send your detailed resume in MS Word format

(Indicating Reason of Leaving, Availability Period, Last Drawn & Expected Salary) to

Personnel Reg No: R1333126

EA Licence No: 02C3423

We regret that only shortlisted candidates will be notified

Selina Lim Siew Yen EA License No.: 02C3423 Personnel Registration No.: R1333126

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