Regulatory Affairs Consultant Safety/Labelling

3 miesięcy temu

Poznań, Polska Pharmiweb Pełny etat
Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a Regulatory Affairs Consultant - Safety/Labelling to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations.

Key responsibilities will include:
  • Acting as expert for labelling-related activities
  • Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution
  • Developing, supporting and reviewing labelling and/or safety-related content
  • Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels
  • Advising on the regulatory requirements for labelling updates in different global regions e.g. EU and ROW.
  • Experienced in managing responses to regulatory authoring questions and negotiating company positions with regulatory authorities


Skills and experience:
  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
  • 3-5 years of experience in an industry-related environment
  • Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role
  • Experience interacting with a regulatory authorities
  • Critical thinking and problem-solving skills
  • Project leadership and management knowledge
  • Excellent interpersonal and intercultural communication skills, both written and verbal

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