Regulatory Affairs Manager

vor 4 Wochen

Northeim, Niedersachsen, Deutschland GULP – experts united Vollzeit
Regulatory Affairs Manager

We are seeking a highly skilled Regulatory Affairs Manager to join our team at GULP – experts united. As a key member of our team, you will be responsible for managing the Regulatory Affairs department, ensuring compliance with regulatory procedures and workflows, and developing optimal strategies for our clients.

Your Responsibilities
  • Manage the Regulatory Affairs department, including the preparation, review, processing, and submission of documents to relevant authorities.
  • Develop and implement regulatory guidelines to ensure compliance with regulatory requirements.
  • Review and comply with regulatory procedures and workflows to ensure seamless operations.
  • Develop optimal strategies for regulatory compliance and risk management.
  • Interface with global regulatory authorities and external consultants to ensure compliance and stay up-to-date with regulatory changes.
  • Train, mentor, and supervise employees, consultants, and contractors in the area of regulation, and develop the team to ensure expertise and knowledge.
  • Support interdisciplinary teams as an advisor on regulatory issues, providing guidance and expertise to ensure compliance and success.
Your Profile
  • You have successfully completed your studies with a scientific focus.
  • Experience in the field of medical devices or in the biotechnology industry.
  • Proven experience in actively leading a team.
  • Very good knowledge in the interpretation of regulations, guidelines, policy statements.
  • You are experienced in the preparation of marketing authorization applications.
  • Prioritization of work packages, both for yourself and for your team.
  • You enjoy working effectively and cooperatively in cross-functional international teams.
  • Fluent written and spoken German and English, and a willingness to travel (max. 10%) round off your profile.
  • You identify with our values of sustainability, openness, and joy, and are motivated to work in a dynamic company.

We offer a comprehensive social package, attractive fixed salary, and opportunities for personnel development. If you are a motivated and experienced Regulatory Affairs Manager looking for a new challenge, please apply to join our team at GULP – experts united.

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