Regulatory CMC Specialist

3 days ago


Cork, Cork, Ireland beBeeKnowledge Full time €100,000 - €107,300
Regulatory CMC Specialist

As a key member of our team, you will play a crucial role in supporting the completion of Module 1 CMC-related information and regional information for various submissions.

This involves preparing and setting up CMC documents in our regulatory information management system, working closely with stakeholders to ensure timely submission and registration of products in global markets.

Key Responsibilities:
  • Developing and utilizing information management expertise and country-specific knowledge to support regulatory documentation.
  • Preparing and requesting necessary documentation for product registration, including COAs, FDA Certificates, and Regulatory Letters.
  • Overseeing and managing activities to register new products and renew existing products in global markets.
  • Providing business process knowledge and regulatory subject matter expertise to stakeholders.


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