Regulatory Affairs Specialist

Responsibilitis:

• Prepare and manage new product submissions for regulatory approval to the local Health Authority (HA). Both eCTD and paper submissions (on project basis only)
• Liaise with Global regulatory colleagues to execute the approved regulatory filing strategies for the region.
• Labeling: Prepare files, liaise with partners, submit to HA, track, archive and manage label update submissions across Middle East
• Prepare and submit for HA review - CMC amendments to product dossiers.
• Respond to HA queries on both new product and amendment submissions.
• Life cycle management of registered drug products
• Keep track of periodic license renewals and submit to HA so as to maintain uninterrupted supply of drugs to patients.
• Liaise with local marketing and market access divisions to provide regulatory support.This includes formal quarterly regulatory feedback sessions.
• Review and approve all local artwork
• Participate in site to market meeting with the cross functional teams to plan new product launch.
• Attend quarterly Gulf compliance committee meetings and keep track of compliance topics.
• Regulatory review of promotional material and clinical trial study medicationlabeling.
• Communicate with HA regarding the Client's initiated product license withdrawals and recalls, as per the directions from Global/SOP.
• Liaise with local partners to manage day to day regulatory activities in the region
• Update VERITY (Regulatory information repository), local archives and local labelling SharePoint
• Support South Africa regulatory activities