Lead Regulatory Affairs Specialist- Global CMC Submissions
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About The Position
Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an on-site Lead Regulatory Affairs Specialist- Global CMC Submissions. This on-site position is responsible for supporting day to day Regulatory Affairs (RA) activities at SPL, Mobren as well as supporting external customer requests. Responsibilities include maintaining and responding to established timelines for reports such as Drug Master Files (DMF) and annual updates/amendments in compliance with ICH Q7, 21 CFR 314.420 and other regulations as applicable. Strong oral and listening communication skills are required to support external and internal customers as well as regulatory agencies. Exceptional writing skills supporting technical subjects and regulatory documents are essential. Attention to detail and working independently with minimal supervision is required. This position reports to the RA Manager.
