Global Regulatory Affairs Expert

2 weeks ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €101,041 - €114,924

Job Title: Global Regulatory Affairs Manager

Job Description

The role of the Global Regulatory Affairs Manager is to develop and implement regulatory strategies that ensure compliance with global regulations. This involves staying up-to-date with changing regulatory requirements, assessing risks, and making informed decisions to mitigate these risks.

  • Demonstrate expertise in CMC regulatory affairs, including knowledge of global regulatory requirements, policies, and procedures.
  • Develop and implement robust regulatory strategies to ensure compliance with global regulations.
  • Maintain strong relationships with cross-functional teams, including R&D, Quality, and Global Regulatory Leads.

About Your Skills & Experience

  • Hands-on experience in CMC authoring, including initial registrations and post-approval variations.
  • Solid understanding of cGMPs and development/commercial activities.
  • Technical, functional, and industry knowledge to shape strategic direction of assigned projects.

Benefits

  • Competitive salaries and benefits package.
  • Inclusive work environment that fosters collaboration and innovation.


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