Join to apply for the Regulatory Global Labeling Director role at BioSpace Based in US, can be remote, but some travel to in the US and other locations as needed to support business needs. Summary The Director of Regulatory Global Labeling (REG-GL) is a strategic leadership role working with a team to develop and manage labeling for products worldwide. Responsibilities may include developing labeling content and strategies for Target Product Labeling, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for Use. The incumbent will be responsible for regulatory compliance, competitive, and up-to-date labeling. Responsibilities This position will be responsible for: Lead or direct the creation of high-quality labeling and supporting documents for new or changes to the CCDS or local labeling. Manage the compliance of local labeling against approved CCDS concepts. Lead Product Labeling Teams or serve as leader to Labeling Leads to ensure labeling is compliant with the local regulations, supports business goals, and processes are followed. Present and defend proposed labeling changes in global product information documents, including labeling documents in key markets to Management as required for review and approval. Provide regulatory strategic guidance and oversight of global labeling activities for commercial products and development products in various therapeutic areas as assigned. An active member on Regulatory, Development, Safety, Commercial teams supporting the requirements for labeling claims in-line with corporate goals. Responsible for the development of labeling negotiations strategic plan for the assigned labeling projects and conduct health-authority reviews and label negotiations. Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic labeling plan. Create and lead the development of labeling processes and support system development to enhance labeling processes as needed. Guide launch teams or provide Senior leadership to Labeling Leads on launch strategy for new commercial products or labeling implementation requirements for labeling changes. Experience Required Skills: Experienced leader with management and direct reports. Experience negotiating with internal and external stakeholders on complex regulatory issues. Seasoned regulatory professional with experience in submissions for products in development and commercial products. Thorough understanding of regulatory labeling requirements and strategic labeling planning. Outstanding interpersonal and communication (written and verbal) skills. Excellent writer or labeling content with attention to detail. Prior experience leading cross-functional teams. History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues. Fluency in English as business language, additional languages advantageous. Desired Skills Expertise in global labeling and managing project teams including international teams (not in the same time-zone). Biologics and rare disease experience is desirable. US labeling expertise required, with additional International and Core Labeling experience desired. Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.

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