Associate Director, Regulatory Labeling

Summary

Join Scholar Rock as an Associate Director, Regulatory Labeling, a leadership role overseeing global product labeling content and strategy across various drug development stages. You will develop and implement labeling processes, generate core data sheets, prescribing information, and patient information leaflets. This position requires leading the Labeling Working Group, ensuring regulatory compliance, and improving labeling processes. The role also involves strategic input for health authority interactions and supporting commercialization efforts. The ideal candidate possesses extensive experience in global regulatory labeling and a strong understanding of relevant regulations and guidelines.

Requirements

• Bachelor’s degree or advanced scientific degree (MSc, PhD, PharmD)
• 5+ years of direct experience in regulatory affairs global labeling
• Experience that demonstrates ability to create development labeling processes and documents (initial CCDS)
• Ability to research and understand complex scientific and regulatory information and distil important aspects for impact to labeling
• Strong project management skills to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory labeling in a systematic and efficient manner
• In-depth and practical knowledge of labeling requirements globally (USPI and SmPC required), including development and life-cycle management of local PIs and PILs

Responsibilities

• Hold primary responsibility for development of product labeling, including core labels and local US and EU labeling
• Conduct research related to labeling precedent, regional regulatory policies, and other topics, as necessary, to advise on potential labeling impact, strategy, or outcome
• Lead the Label Working Group (LWG) for assigned programs/products to drive alignment of labeling content and strategy and represent the regulatory labeling function at governance meetings
• Provide input into strategy for Health Authority interactions regarding all aspects of labeling, including submissions, responses to questions, and negotiations
• Be accountable for compliance with health authority requirements, labeling governance requirements and associated business processes
• Lead the continuous improvement of labeling processes to enhance efficiency. Provide department/company training on labeling practices and policies
• Provide assistance to the Regulatory Affairs Advertising and Promotion function to support the commercialization of marketed products