Regulatory Affairs Specialist
24 hours ago
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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