Regulatory Affairs Specialist

3 weeks ago


Uxbridge, United Kingdom Regeneron Full time
Job Title: Regulatory Affairs Senior Associate

Regeneron is seeking a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our products with global regulatory requirements.

Key Responsibilities:
  • Regulatory Assessment and Compliance: Conduct thorough assessments of changes to ensure compliance with global regulatory requirements, including CMC and GMP regulations.
  • Submission Strategies: Collaborate with cross-functional teams to develop and implement submission strategies that meet regulatory requirements and support clinical supply.
  • Regulatory Release and QP Certification: Support the preparation and submission of regulatory release packages and QP certification processes.
  • Communication and Stakeholder Management: Foster strong relationships with internal and external stakeholders, including IOPS and Global Development teams, to ensure effective communication and collaboration.
  • Project Management: Work closely with management and stakeholders to ensure timely completion of projects and effective tracking of regulatory submission packages and approval status.
Requirements:
  • Education: Bachelor's degree in a relevant technical or scientific discipline.
  • Experience: Minimum 4+ years of pharmaceutical/biotech industry experience, including 3+ years of relevant CMC experience.

Regeneron is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to providing a workplace that is inclusive and respectful of all employees. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.



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