Regulatory Affairs Specialist

2 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 Submission Forms: Support the development and submission of regulatory forms to ensure timely and compliant regulatory release and QP certification.
  • Communication and Collaboration: Foster strong relationships with internal and external stakeholders, including IOPS and Global Development teams.
  • Project Management: Work closely with management and stakeholders to ensure assessments, strategies, and project status are communicated effectively.
  • Regulatory Tracking: Utilize procedures and systems to track global 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 reasonable accommodation to qualified applicants with disabilities or chronic illnesses.



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