Specialist, Regulatory Affairs FDF

About the role

Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.

What you'll do

• Collection of information and preparation of dossiers and variation packages as and when required
• Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA…
• Support in activities related to pharmacovigilance
• Support in evaluation of CMC data required to support dossiers and variation packages
• Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures

What you need

• 3–5 yrs of experience
• Regulatory affairs
• Chemistry
• Pharmacovigilance
• SOP writing
• Performance management
• Any graduate