Associate Director Global Regulatory Affairs

Associate Director

We are seeking an experienced Associate Director, Global Regulatory Affairs (RA) Labeling Lead to join the Plasma-Derived Therapies (PDT) organization at a leading global biopharmaceutical company. This role will lead global regulatory labeling strategy and lifecycle management for pharmaceutical drug and device products, working closely with Clinical, Pharmacovigilance, Medical Affairs, Legal, Commercial, Regulatory, and other cross-functional teams.

Lead global labeling strategy and lifecycle management for CCDS, USPI, and EU SmPC. Develop and implement regulatory labeling strategies supporting product development, commercialization, and global expansion. Lead global labeling teams and cross-functional labeling projects. Interpret scientific, clinical, medical, and regulatory data to develop effective labeling strategies. Provide strategic guidance on US and EU labeling requirements and Health Authority expectations. Support combination product/drug-device labeling strategies. Develop labeling for new products and manage updates throughout the product lifecycle. Incorporate Health Authority feedback, regulatory precedent, and guidance into labeling strategies. Lead cross-functional discussions and drive consensus among global stakeholders. Prepare submission-ready labeling components and support Health Authority interactions. Ensure appropriate document control, version control, QC, tracking, and archival of labeling documentation. Partner with Regulatory Intelligence teams to assess changes in labeling regulations and their impact on products. Develop and deliver regulatory labeling training programs. Identify process and system improvements to enhance labeling quality, compliance, and efficiency.

710+ years of experience in the biopharmaceutical/pharmaceutical industry. 57+ years of direct experience in global, US, or EU regulatory labeling preferred. Strong expertise in Regulatory Affairs Labeling. Hands-on experience developing and maintaining: Company Core Data Sheet (CCDS) US Prescribing Information (USPI) EU Summary of Product Characteristics (SmPC) Strong understanding of US and EU pharmaceutical labeling regulations and guidance. Experience with SPL (Structured Product Labeling) requirements, including legacy and PLR labeling. Experience with drug-device/combination product labeling preferred. Strong understanding of pharmaceutical drug and device development. Experience working with Electronic Document Management Systems (EDMS) and end-to-end labeling tracking systems. Excellent stakeholder management, communication, strategic thinking, and influencing skills. Ability to lead global, cross-functional teams and influence senior stakeholders without direct authority.