Executive - Regulatory Affairs

About the role

To support all products submissions including new applications, variations and renewals to ensure supplies to the EU & RoW markets in accordance with government legislation, relevant guidelines and national requirements. External - External (Country Distributors, Health Authorities (HA), external partners, CMO's)

What you'll do

• Preparation and submission of regulatory documentation for new marketing authorisations, variations and renewals for assigned products and/or markets
• Prepare and review all new applications and other submissions including dossier components, SmPC's, labelling etc. for compliance with all applicable regulations
• Initiation of Change Controls in applicable systems for all regulatory driven change controls
• Act as liaison between single or multiple project teams to obtain submission related information
• Author response packages to Requests For Information (RFI) received from Health Authorities in accordance with internal timelines and HA imposed deadlines

What you need

• 2–4 yrs of experience
• Regulatory affairs
• Documentation
• SOP writing
• Pharmacovigilance
• ICU care
• Quality control
• M.Sc or B.Pharm or M.Pharm