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Regulatory Affairs Associate

2 weeks ago

Cork, Cork, Ireland Eli Lilly and Company Full time

Eli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. As a Regulatory Affairs Associate, you will play a critical role in ensuring that our company's products are safe and effective for use by patients. You will be responsible for managing and maintaining accurate records of regulatory submissions, and for collaborating with cross-functional teams to develop and implement effective regulatory strategies.

Key Responsibilities:
  • You will be responsible for managing and maintaining accurate records of regulatory submissions, including clinical trial reports and product labeling.
  • As a key member of the regulatory affairs team, you will collaborate with writers to develop high-quality regulatory documents, and evaluate and resolve conflicts related to regulatory content and deadlines.
  • You will also be responsible for staying up-to-date on changing regulatory requirements and guidelines, and for identifying opportunities for process improvements and implementing changes to enhance the regulatory process.