Director Regulatory Affairs Innovative Medicines (IM) Labeling

Director Regulatory Affairs Innovative Medicines (IM) Labeling

The Director of Regulatory Affairs, Innovative Medicines (IM) Labeling serves as a cross-functional subject matter expert for matters related to US drug product labeling, including all relevant FDA regulations and guidances as well as internal IM labeling processes and requirements. The Director develops and maintains the labeling for an individual portfolio of assigned product(s), including serving as the labeling contact with FDA and leading cross-functional labeling and Company Core Data Sheet (CCDS) development teams. Oversees development and maintenance of labeling SOPs and other process documents. Engages in strategic and cross-functional collaboration on various labeling development and governance committees.

Bachelor's degree required, preferably in a life sciences, pharmacy, or related field. Minimum of 6 years of relevant experience in the biopharmaceutical industry, with a substantial and dedicated focus on U.S. drug or biologic labeling across multiple lifecycle stages. Experience supporting both small molecule and biologic products preferred; combination product experience a plus. Expert-level knowledge of FDA labeling regulations and guidance documents, including requirements for format, content, and post-marketing change submissions. Thorough familiarity with: Structured Product Labeling (SPL) and drug listing; Company Core Data Sheet (CCDS) and Company Core Safety Information (CCSI) documents; Summary of Product Characteristics (SmPC); document management systems Strong analytical and writing skills; ability to distill complex scientific and regulatory information into clear, precise labeling language. Demonstrated ability to influence and to build credibility as a trusted advisor to labeling colleagues as well as across multiple functions and seniority levels in a collaborative, learning environment Basic understanding of drug development and worldwide regulatory labeling guidelines and their application to US labeling guidance in a global company Exceptional attention to detail, organizational skills, and the ability to manage multiple competing priorities in a fast-paced environment.