Senior Regulatory Affairs Specialist

3 weeks ago


United Kingdom Regeneron Ireland DAC Full time £12,000
Job Summary

We are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron Ireland DAC. As a key member of our regulatory affairs team, you will be responsible for ensuring the compliance of our products with global regulatory requirements.

Key Responsibilities
  • Review and assess regulatory submissions to ensure compliance with global regulatory requirements.
  • Collaborate with cross-functional teams to support submission strategies and impact on supply and regulatory release processes.
  • Support the development and maintenance of regulatory submission forms to ensure compliance with regulatory requirements.
  • Foster strong communication and working relationships between internal stakeholders and external partners.
  • Stay up-to-date with changes in regulatory requirements and ensure that our products remain compliant.
Requirements
  • Bachelor's degree in a relevant technical or scientific discipline.
  • At least 4 years of experience in the pharmaceutical or biotech industry, with a minimum of 3 years of relevant CMC experience.
  • Strong understanding of quality principles in a regulated manufacturing environment.
  • Excellent communication and interpersonal skills.
What We Offer

We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees. Regeneron is an equal opportunity employer and welcomes applications from diverse candidates.



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