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Job Description:
Job Description Summary
Supports MEA Regional Director of Regulatory Affairs & Scientific Office.
Ensure product regulatory compliance with applicable regulations and standards in MEA.
Main responsibilities / job expectations
Works autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific Office, to oversee day-to-day Regulatory Affairs activities for specific area(s) of responsibility.
Regulatory Operations
Supports MEA Regional Director of Regulatory Affairs & Scientific Office with the following activities but not limited to:
Supports the coordination, compilation and submission of regulatory submissions for new and/ or renewal of registration, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements. Regular follow-up on submitted dossiers within responsibility. Interacts with internal and/or external stakeholders.
Ensures proper archiving for submitted and/ or approved regulatory activities in-line with effective SOPs and Ipsen s ways of working.
Update the applicable, internal trackers and/or database.
Education:
Pharmacy bachelor's degree is a must.
Experience:
3 - 6yrs regulatory experience in healthcare and/or pharmaceutical industry is a must.
Languages:
Arabic and English are must. Additional languages will be a plus.
Key Technical Competencies Required
Good working knowledge with Ms-Office.
Good understanding of the regulations.
Acts with integrity.
Provides solutions to a variety of problems of limited scope and complexity.
Agility.
Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.
DETAILS TO REGISTER FOR THIS JOB:
NOTE: ATS-compliant CV is MANDATORY!
https://ipsen.wd3.myworkdayjobs.com/Ipsen_Careers/job/Dubai/Associate-Manager-Regulatory-Affairs_R-16154?source=APPLICANT_SOURCE-6-4NOTE: ATS-compliant CV is MANDATORY!
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