Regulatory Affairs Specialist

24 hours ago


Slough, Slough, United Kingdom UCB Full time
About the Role
We are seeking an experienced Regulatory Submission Manager to join our team in Brussels, Germany or Slough. As a key member of the Business Submissions & Operations (Regulatory Operations) team, you will be responsible for performing publishing and/or compilation activities for reports and submissions to Regulatory Authorities.

Responsibilities
  • Ensure compliance with internal business processes and regulatory requirements by managing submission timelines.
  • Produce electronic output for submissions and conduct technical validation to ensure authority requirements are met.
  • Coordinate and track delivery of submissions to affiliates/partners or regulatory authorities and confirm receipt upon request.
  • Lead or participate in developing global processes and standards for regulatory submissions and technology projects.
  • Verify dossiers comply with international and local regulatory guidelines.

Requirements
  • Bachelor's degree required.
  • Extensive knowledge of Microsoft Word and Adobe Acrobat functionality essential.
  • Experience in preparing documents for regulatory submissions to meet authority requirements and company standards necessary.
  • Detailed knowledge of eCTD specifications and validation requirements required.

What We Offer
  • A competitive salary of $85,000 - $110,000 per annum.
  • A comprehensive benefits package including health insurance, retirement plan, and paid time off.
  • The opportunity to work with a global biopharmaceutical company dedicated to neurology and immunology research.

About Us

UCB is a leading biopharmaceutical company with around 8,500 employees worldwide. We value diversity and inclusion in the workplace and welcome applications from all qualified candidates.



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