Regulatory Strategist / Manager (Regional)

Location Tuas, Singapore
Job reference RN SEL _1564736679
Salary S$6000 - S$7500 per month
Consultant name Selina Lim Siew Yen
Consultant email
Consultant contact no. 65515298
EA License No. 02C3423
Consultant Registration No. R1333126
Job Description:
  • Manage post approval submissions for a group of assigned market
    Manage post approval strategy that include timeline and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready for the assigned market
  • Ensure a collective documents such as electronic, paper copy, and HA portal are produced and dispatched to assigned markets according to their defined filing plan and are submission ready
  • Work in collaboration across the regulatory organization with stakeholders such as Product Strategist and in-market Strategists to deliver efficiencies in Regulatory submissions and processes
  • Ensures the processes transparency and excellence in execution of regulatory strategies
  • Capable of authoring some local submission components in relevant databases
    Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
  • Understand local regulations and trends for assigned markets
  • Candidate must possess at least a Bachelor's Degree, Professional Degree in Medicine, Medical Science, Pharmacy or equivalent
  • Minimun 5 years of regulatory affairs experience in pharma or related industry
  • Experience in submission processes and product lifecycle management processes
  • Experience handling medicinal product registration and maintenance
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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