Regulatory Global Labeling Director

Role Summary

Based in the US, this role can be remote with some travel to the US and other locations as needed to support business needs. The Director of Regulatory Global Labeling (REG-GL) is a strategic leadership role responsible for developing and managing labeling for products worldwide. Responsibilities include developing labeling content and strategies for Target Product Labeling, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for Use. The incumbent ensures regulatory compliance, current labeling standards, and leads cross-functional Product Labeling Teams as a Global Labeling Lead or supervises staff, directing labeling content, requirements, and strategies for optimal outcomes. The role also manages regulatory health authority interactions and negotiations, provides end-to-end labeling oversight, and mentors labeling professionals to achieve regulatory objectives.

Responsibilities

• Lead or direct the creation of high quality labeling and supporting documents for new or changes to the CCDS or local labeling. Review of summary documents such as clinical overviews to ensure the labeling message is consistent with the overall representation of a marketing application.
• 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. May include presenting and influencing Regulatory Leadership and/or Executive Labeling Committee on an ad-hoc/issue-driven basis for assigned projects/products.
• An active member on Regulatory, Development, Safety, Commercial teams supporting the requirements for labeling claims in-line with corporate goals. This may include interactions with Regulatory International and regional Partners.
• Responsible for the development of labeling negotiations strategic plan for the assigned labeling projects and conduct health-authority reviews and label negotiations (in writing, phone or in person as needed). Lead US and EU labeling negotiations for the assigned products. Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed.
• 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. May interact with Commercial, Supply Chain and Technical Operations staff.

Qualifications

• Required: A minimum of 7 years required of industry experience and extensive experience (at least 4 years) in labeling; alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.
• Required: Experienced leader with management and direct reports.
• Required: Experience negotiating with internal and external stakeholders on complex regulatory issues.
• Required: Seasoned regulatory professional with experience in submissions for products in development and commercial products.
• Required: Thorough understanding of regulatory labeling requirements and strategic labeling planning.
• Required: Outstanding interpersonal and communication (written and verbal) skills.
• Required: Excellent writer or labeling content with attention to detail.
• Required: Prior experience leading cross functional teams.
• Required: History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
• Required: Fluency in English as business language, additional languages advantageous.
• Preferred: Expertise in global labeling and managing project teams including international teams (not in the same time-zone).
• Preferred: Biologics and rare disease experience is desirable.
• Preferred: US labeling expertise required, with additional International and Core Labeling experience desired.

Skills

• Leadership and people management in labeling programs
• Regulatory negotiations and stakeholder management
• Strategic regulatory labeling planning and interpretation of regional requirements
• Cross-functional collaboration with Regulatory, Development, Safety, Commercial, and other teams
• Strong written and verbal communication; clear labeling content
• Attention to detail in labeling documentation
• Experience with regulatory submissions for development and commercial products

Education

• Science-based BS or MS with requisite experience and demonstrated capability.
• Advanced degree (MD, PhD, PharmD) preferred.

Additional Requirements

• Travel: Some domestic and international travel as needed.