Regulatory Compliance Specialist

2 days ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time

We are seeking a Regulatory Compliance Specialist to join our team at AGC Biologics in Bresso, Italy. The ideal candidate will have a strong understanding of quality control and compliance principles, with experience in monitoring laboratory activities and coordinating data integrity initiatives.

Job Summary

This role is responsible for ensuring that all laboratory activities are conducted in accordance with regulatory requirements, including the release of batches within specified timelines. The successful candidate will work closely with the QC team to manage CAPA and deviation activities, provide training on methods and procedures, and support the implementation of new processes.

About the Role

The Regulatory Compliance Specialist will be responsible for:

  • Monitoring the progress of laboratory activities related to the issuance of IPC/CDA for batch release within specified timelines
  • Coordinating data integrity activities for QC documents (stability reports, certificates of analysis, IPCs, ATF, etc.)
  • Collaborating with the QC team to manage CAPA and deviation activities
  • Providing training on methods and procedures using the TWS system
Requirements

To be considered for this role, you will need:

  • A degree in biotechnology or a similar field
  • Excellent written and spoken English skills
  • Ability to work effectively in a team environment
About AGC Biologics

AGC Biologics is a global biopharmaceutical company dedicated to bringing hope to life by enabling life-changing therapies for patients around the globe. Our mission is to work side by side with our customers to improve patients' lives by bringing new biopharmaceuticals to market.

What We Offer

We offer a highly competitive compensation package, a friendly and collaborative culture that values personal initiative and professional achievement, and opportunities for growth and development. AGC Biologics is an equal opportunity employer and welcomes applications from diverse candidates.



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