Regulatory Affairs Manager

Location: Singapore
Salary: competitive
Job Type: Permanent
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Regulatory Affairs Manager

Responsibilities:

  • Review and develop regulatory dossiers with content and format complying to applicable regulations.
  • Provide regulatory oversight and implementation of strategic submission plans to ensure maintenance of Marketing Authorisations.
  • Support the submission and approval of New Drug Applications.
  • Work with line management to provide a level of regulatory expertise (e.g. requirement for specific regulatory expertise)
  • Consult externally qualified consultants when appropriate (e.g. requirement for specific regulatory expertise)
  • Coordinate and manage Regulatory Affairs activities in APAC across local affiliates/licenses.
  • Gain and maintain knowledge of relevant internal Standard Operating Procedures (SOP) and appropriate external guidance documents e.g. ASEAN Guidelines.

Candidate should possess:

  • A minimum of 6 - 8 years of regional RA experience
  • Experience in New Drug Applications
  • Experience in biologics is preferred
  • Good written and communication skills
  • Clinical experience is preferred but not mandatory

If you meet the essential requirements for this position, please send your latest CV through the link provided , or call Vanessa Tan at +65 6871 4700 for further information.

Only shortlisted candidates will be notified via email.

Registration no: R1873695

EA Licence no: 16S8216

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:

International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Global Recruiters 2017

Highly Commended for Best Large Recruitment Business 2017

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