Regulatory Affairs Specialist

2 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom Biogen Full time
About This Role

We are seeking a highly motivated and proactive graduate to join our Regulatory Affairs team as a Regulatory Affairs Specialist. In this role, you will be responsible for coordinating and enabling implementation of artwork changes for EU marketed products, ensuring compliance with regulatory requirements.

Key Responsibilities

  • Lead change management meetings and review artwork to ensure regulatory compliance.
  • Collaborate with the EU regulatory lead to conduct regulatory assessments and update internal systems.
  • Support the planning and preparation of regulatory submissions for assigned projects.
  • Act as a point of contact with the artwork team to ensure consistency and increase compliance.

Requirements

  • A recent postgraduate degree in life sciences.
  • Proficient computer skills with the Microsoft suite of products, primarily Word, Excel, PowerPoint.
  • Fluent in English, with strong written and verbal communication skills.

About Biogen

We are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.



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