Job closed
Ref: NP314-724
Job description / Role
• Compile and submit regulatory documents according to regulatory requirements. Regular follow up on the submitted files. Ensure timely submissions as well tightly manage deficiency responses.
• Feed the trackers with accurate information and provide them with input for any regulatory plan rolled out
• Work with the Regulatory lead to develop and execute regulatory plans for complex projects including transfer of the newly acquired products and maintenance of licenses/authorisations for existing marketing authorization
• Work on Renewals
• Provides solutions to a variety of problems of moderate scope of complexity. Interacts with internal and/or external clients.
• Labelling: annotation and review of the artworks in compliance with local labelling guidelines. Artwork release when any approval is received and ensures all relevant stakeholders is informed
• Work cross functionally on new products launches and products acquisition. Build better and stronger relationships with relevant internal and external stakeholders
• Validating Promotional materials, abbreviated prescribing information and artworks Ensure a proper archiving for any submitted dossier
• Update the internal trackers
• Work on assigned projects to assist other affiliate where needed based on the business priority
• Identify changes and modifications in the healthcare regulatory environment; and communicate those changes to appropriate individuals and departments for implementing into the organization’s processes
• Assigned markets: Algeria/Morocco/Tunisia/Lebanon and Bahrain
Requirements
• Bachelor’s degree in a scientific discipline, required
• Good verbal and written communication skills
• Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities
• English /Arabic and French speaker
• Strong interpersonal skills
• Demonstrates the ability to provide regulatory assessment to other departments with little supervision
• Demonstrates the ability to coordinate submissions independently in a time intensive situation
• Good team player
About the Company
Inspire Selection is an award winning recruitment agency, headquartered in Dubai which recruits across the Middle East region. We employ highly knowledgeable, professional consultants who are experts in connecting the right people with the right opportunities. Our reputation has been built upon our honesty, integrity and our ability to source candidates of the highest calibre right across our specialist sectors. As a result, we are recruitment partners to a wide spectrum of organisations - from leading blue chip companies to smaller, local businesses. Sectors we cover include HR, Administration, Finance & Accounting, Legal, Sales & Marketing including Digital Marketing, IT, Oil/Gas/Energy, Engineering, Procurement, Manufacturing, Higher Education.