Informacje o stanowisku

Regulatory Affairs Manager / Senior Manager in Global Labeling

For our Client, one of the largest Pharmaceutical companies worldwide, we are looking for a Regulatory Affairs Manager / Senior Manager in Global Labeling, who will ensure the quality of primary and derived labeling documents and provide support for these documents.

If you have relevant experience and would like to participate in the global labeling strategy, apply for this role.

What We Expect

• Educational background (university degree in Life Sciences, Pharmacy, etc.)
• Professional experience in the pharmaceutical/medical industry
• Experience in Regulatory Affairs with a focus on product labeling/labeling regulations
• Understanding of drug development, including the therapeutic area(s) and individual product knowledge
• Expertise in writing pharmaceutical labeling
• Strong verbal and written communication skills

What We Offer

• Beneficial leave policies
• Medical Care program & Life Insurance
• Pension plan
• Reimbursement of Exercises/Wellness Programs and Cultural Activities
• Company car
• Participation in developing and maintaining primary and derived labeling documents (develop, revise, review, and gain agreement on all labeling documents)
• Cooperation with other teams on the dissemination of derivative labeling documents and support documentation
• Ensuring the quality of delivered labeling (e.g., alignment of labeling text with data, regulatory requirements, consistency)
• Participation in the continuous improvement of the labeling process
• Implementation of the global labeling strategy including the development of target labeling

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