Regulatory Affairs Specialist (Pharmaceutical/ Medical Devices)

Regulatory Affairs Specialist (Pharmaceutical/ Medical Devices)

GENERAL SUMMARY OF ROLE:

This role will be responsible for all the domestic and regional regulatory affairs (RA), including but not limited to NDAs, variations and registration renewals in Singapore and Asian countries. She (or he) shall also be responsible for establishing domestic and regional pharmacovigilance for the products.

Responsibilities:

• Responsible for the preparation and documentation of regulatory submissions to government agencies.
• Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Normally receives no instructions on routine work, general instructions on new assignments.
• May provide leadership by assigning wor...