Regulatory Affairs Manager (m/f/d)

Your Profile:

• Master's degree in Life Sciences (e.g., Biology, Molecular Biology, Biochemistry, Pharmacy) or a related scientific discipline
  
• Minimum of 5 years of Regulatory Affairs experience within pharmaceutical drug development, ideally in a global environment
  
• Strong understanding of regulatory submission and approval processes, including experience with major regulatory frameworks such as EU and/or US
  
• Ideally experience supporting the registration and lifecycle management of biologic products
  
• Solid knowledge of pharmaceutical regulations and regulatory intelligence, with the ability to interpret evolving requirements and provide sound regulatory guidance
  
• Excellent communication and stakeholder management skills, with the ability to collaborate effectively across cross-functional and international teams; fluent in written and spoken English
  
• Highly detail-oriented with strong analytical skills, including the ability to evaluate scientific data and translate complex information into high-quality regulatory documentation; proficient in standard computer applications and digital systems

Your Tasks:

• Lead regulatory activities for assigned lifecycle management projects, including global product expansions
  
• Develop and execute regulatory strategies for post-approval activities, ensuring alignment with business objectives and global regulatory requirements
  
• Prepare, coordinate and submit high-quality regulatory documentation, including briefing packages, variations, supplements and marketing authorization submissions
  
• Act as the Regulatory Affairs lead within cross-functional project teams, providing strategic guidance throughout post-authorization processes
  
• Coordinate responses to health authority questions and regulatory review procedures, ensuring timely and compliant interactions with regulatory agencies worldwide
  
• Monitor and interpret evolving regulatory requirements, guidelines and legislation, communicating relevant updates to stakeholders and supporting organizational compliance
  
• Contribute to regulatory operational excellence through process improvements, and the development and maintenance of Regulatory Affairs SOPs and work instructions

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