Regulatory Affairs Associate

Sourcing Statement

You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.

Job Description

Communicate with HQ to get the required registration & re-registration documents in due time.Prepare & submit drug registration files in a timely manner.Follow up of the files with MOH officials to achieve a favorable outcome.Get the registration & re-registration approvals in due time.Re-registration of the old products (registered since 10 years) – In due time & with minimum supervision.Develop and maintain good working relationships with other Novartis departments both locally and with HQ and with health authority.Submission & approval of production transfer in due dates.Submission & approval of variations in due dates.Package insert update and new indications approvals in due dates.Post registration variations submission & approval in due dates according to marketing plans/ Global guidelinesProvide adequate training and guidance to all junior regulatory associates as requested by Drug Regulatory Affairs Head.Assist Drug Regulatory Affairs Head in maintaining & improving strong MOH relationships through:Attending/participating/contributing in local authority’s annual & regular meetings/conferences.Utilizing public relations motivation tools to strengthen relationship with MOH officials.Promotional Materials review and approvalDRAGON system maintenance and updateChange Control handling.Secure pre-license sales importation approvals in due date and as per marketing requests

Minimum Requirements

Pharmacy with or without postgraduate qualifications1-2 years experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.

Job ID 223820BR

#GDG