Regulatory Affairs Manager

3 weeks ago


United Kingdom Regeneron Ireland DAC Full time £12,000
Job Title: Regulatory Affairs Manager

Regeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support our CMC development activities from a regulatory standpoint. The successful candidate will participate in cross-functional meetings, identify regulatory issues, and suggest strategies to mitigate risks.

Key Responsibilities:
  • Review regulatory filing documents to ensure compliance with applicable regulations and guidelines.
  • Participate in discussions to develop regulatory strategies for CMC/CP product development activities.
  • Perform compliance activities to determine regulatory impact and associated submission requirements.
  • Assist specialists and colleagues in regulatory assessment of compliance tasks.
  • Support preparations for interactions with global regulatory authorities.
  • Develop and create Working Instructions, SOPs, and/or Reviewer's Guide to facilitate consistent and efficient practice.
Requirements:
  • Bachelor's degree in a relevant technical or scientific discipline.
  • Minimum 5-6 years pharmaceutical/biotech proven experience.
  • Strong understanding of current CMC RA worldwide regulations.
  • Experience in dealings with FDA and other regulatory authorities.
What We Offer:

Regeneron is an equal opportunity employer and offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees. We are committed to diversity and inclusion and welcome applications from all qualified candidates.



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