Associate Manager Regulatory Affairs

at  Ipsen Pharma SAS

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.

Please refer the Job description for details