Regulatory Affairs Manager (m/f/d)

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

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Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3cbb1cf05543

Job Views:

3

Posted:

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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

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