Regulatory Affairs Expert

3 weeks ago

Sanford, North Carolina, United States Astellas Pharma Full time

Astellas Pharma Inc. is seeking a highly skilled Regulatory Affairs Expert to join our team at our cGMP regulated manufacturing facility in Sanford, NC. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the highest standards of quality and regulatory compliance.

The successful candidate will have a strong background in regulatory affairs and quality systems, with experience in managing multiple projects simultaneously. You will be responsible for preparing and completing audit reports, communicating results internally, and maintaining the Approved Supplier List in support of the external supplier lifecycle.

This is an on-site role requiring minimal travel, but may include occasional trips to other Astellas Gene Therapies manufacturing facilities or domestically up to 15% for audit support, as required.

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