Regulatory Labeling Lead - Middle East Markets

Abbvie Biopharmaceuticals GMBH - REP.OFFICE; Dubai, Al Ain; On-site; AED 120,000 - 240,000; Full time

Job summary

AbbVie Middle East affiliate in Dubai is seeking a Regulatory Labeling Specialist to coordinate labeling activities for the Middle East Gulf Levant region. You will lead preparations of SmPCs, PILs, and labeling for regulatory submissions, ensure GLS uploads, and maintain labeling documents in line with local laws.

You will collaborate with Regulatory Affairs, Marketing, and Manufacturing to implement labeling changes on time.

Qualifications

• Bachelor degree.
• Proficiency in written and spoken English.
• IT literate and able to use labeling systems.

Responsibilities

• Coordinate labeling activities for the Middle East Gulf Levant region.
• Prepare SmPCs, PILs and labeling for regulatory submissions.
• Upload to GLS and manage local product information documents.
• Communicate labeling changes to local Marketing, Sales and Medical teams.
• Ensure compliance with local regulatory requirements and timelines.
• Support cross-functional teams (Marketing, Sales, Medical) on labeling changes.

Skills

Administrative skills

Project management

Communication skills

Problem solving

Attention to detail

Education

Bachelor degree

Tools

GLS (Global labeling system)

Job description

AbbVie Middle East affiliate in Dubai is seeking a Regulatory Labeling Specialist to coordinate labeling activities for the Middle East Gulf Levant region. You will lead preparations of SmPCs, PILs, and labeling for regulatory submissions, ensure GLS uploads, and maintain labeling documents in line with local laws.

You will collaborate with Regulatory Affairs, Marketing, and Manufacturing to implement labeling changes on time.