Regulatory Affairs Manager (m / f / d)

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Regulatory Affairs Manager (m/f/d), Ludwigshafen

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Client:

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3cbb1cf05543

Job Views:

3

Posted:

10.08.2025

Expiry Date:

24.09.2025

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Job Description:

Time for change - time for a new job! You are a regulatory affairs manager looking for a new professional challenge? We offer a secure job, fair compensation, and exciting tasks at an attractive pharmaceutical company in Ludwigshafen. Apply online now! We welcome applications from all qualified persons regardless of disabilities.

Here's what we offer

• Option of permanent employment with our partner
• Extensive social benefits, including Christmas and holiday bonuses
• Up to 30 days vacation per year
• Free online courses
• Support in completing product dossiers, technical files, and responses to information requests for international marketing
• Coordinate and complete documents required by federal agencies, maintain files and electronic document management systems, and work with project teams for product approval
• Operate at middle management level, influencing regulatory processes
• Serve as the primary interface with affiliates to coordinate international regulatory documents and samples for product registration and marketing
• Act as the main contact with German federal agencies, embassies, and consulates for products with manufacturing licenses or marketed within the EU
• Gather documents from EU facilities for product registration
• Coordinate document requests for products approved via the Centralized Procedure but manufactured in Germany
• Work with third-party manufacturers to obtain necessary documents

Your profile

• Bachelor's degree in life sciences, clinical research, or engineering
• Previous regulatory experience preferred
• Experience in a regulated industry or legal environment
• Proficient in English
• Negotiation skills for interactions with government agencies
• Organizational skills to manage data and identify documentation gaps
• Effective communication skills, both oral and written
• Proficiency with Microsoft Office, especially Excel, Word, Outlook, Teams
• Knowledge of database management
• Experience with SharePoint
• Awareness of German regulatory policies for document legalization and submission