Associate Manager Regulatory Affairs
2 weeks ago
**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.
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