Compliance Analyst - regulatory reporting (Louisville, KY)

Amberfield Summit Pharma supports drug development and manufacturing around Louisville. We are hiring a Compliance Analyst to take on regulatory reporting. You would work closely with colleagues in operations, support and management. What you will do • Track findings until they are fixed. • Prepare regulatory filings and audit evidence. • Review processes against regulations and internal policies. • Keep the policy library current and easy to search. • Train staff on requirements for regulatory filings. What we are looking for • Two or more years in compliance, audit or risk. • Comfort saying no politely. • Careful reading and clear writing. Nice to have • Experience with batch records. • Certification in compliance or audit. Working arrangement • Contract for nine months, with the possibility of becoming permanent. • On site in Louisville. • We reply to every applicant.