Regulatory Affairs Manager (Regional)

Location Tuas, Singapore
Job reference RN SEL _1565857127
Salary Negotiable
Consultant name Selina Lim Siew Yen
Consultant email selina.lim@experis.com.sg
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

Requirements:

  • 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

selina.lim@experis.com.sg

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

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup's Global Privacy Policy, please visit https://www.experis.com.sg/privacy-policy