Explore Director, Regulatory Labeling jobs and discover a pivotal leadership career at the intersection of science, regulation, and patient safety. A Director of Regulatory Labeling is a senior strategic expert within the pharmaceutical, biotechnology, and medical device industries, responsible for the end-to-end management of all labeling content for drug or therapeutic products. This role is critical for ensuring that the information communicated to healthcare professionals and patients—via prescribing information, patient leaflets, packaging, and more—is accurate, compliant, and supports safe and effective use. Professionals in these jobs serve as the central authority, bridging deep regulatory knowledge with cross-functional collaboration to guide products from development through global commercialization and post-market lifecycle. The core responsibilities of a Director, Regulatory Labeling typically encompass leading the development and maintenance of the Core Data Sheet (CDS), which forms the foundational labeling document for a product worldwide. They oversee the adaptation of the CDS into all regional labels, such as the USPI in the United States or the SmPC in Europe. A significant part of the role involves spearheading negotiations with global health authorities (like the FDA, EMA, and others) to reach agreement on labeling text during marketing applications and updates. Directors establish and optimize internal labeling processes, SOPs, and governance systems. They provide strategic regulatory guidance to R&D, clinical, commercial, and safety teams, ensuring all labeling decisions mitigate risk and align with both regulatory requirements and the product's therapeutic profile. Leadership duties also include managing a team of labeling specialists, mentoring staff, and overseeing project timelines to meet critical regulatory milestones. Typical skills and requirements for candidates seeking Director, Regulatory Labeling jobs include an advanced scientific degree (e.g., in Pharmacy, Life Sciences, Medicine) and a substantial track record (often 8+ years) in Regulatory Affairs with a dedicated focus on labeling. Comprehensive expertise in global labeling regulations and guidelines is non-negotiable, as is proven experience with major regulatory submissions (IND, BLA, NDA, MAA). The ideal candidate possesses exceptional strategic thinking, meticulous attention to detail, and outstanding negotiation and communication skills to advocate for the company's position with authorities and align internal stakeholders. Strong leadership, project management capabilities, and the ability to interpret complex clinical data into clear prescribing information are paramount. For those who thrive on ensuring scientific precision meets regulatory rigor in a high-stakes environment, Director, Regulatory Labeling jobs offer a challenging and rewarding career path at the heart of bringing vital therapies to market.
