Regulatory Manager

Job title : Regulatory Manager

• Hiring Manager: Head of Site Quality

• Location: Jurong, Singapore

About the Job

The Head of Regulatory Site is responsible to assist the Head of Site Quality for ensuring compliance with relevant worldwide Pharmaceutical Regulation & API regulatory filing (e.g. CEP, CMC, Drug Master File (DMF), New Drug Application (NDA), JNDA, NDS & Marketing Authorisation Application (MAA) of the site.

Main accountabilities

• Defining the potential regulatory impacts of changes made to the site products and services. Acts as the regulatory interface for the site with external and internal partners at the site and within the SANOFI network for evaluating their change requests and maintaining marketing authorizations in all regions of the world.
• Managing the technical writing for the marketing applications of the site products; authoring the variations, the CTD se...