Senior Director – Global Labeling Regulatory Affairs

Senior Director – Global Labeling Regulatory Affairs

Requirements

• Bachelor’s Degree in Life Science or other related discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum of 12 years’ regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 8-10 years’ experience in a regulatory leadership role.
• Strong expertise and knowledge of applicable regulations and standards for FDA and EMA product investigational and commercial labeling and packaging requirements, regulations, and guidelines (USPI and EU SmPC experience required).
• Knowledge of Clinical Supply Packaging and/or Labeling and/or Distribution with external vendors (e.g. technical, process, plan or system).
• Strong collaboration, presentation, communication, interpersonal, and leadership skills.

Responsibilities

• Direct and ensure effective execution of optimal strategies for labeling development by providing global labeling insight, developing and implementing harmonized labeling processes for new product labels and associated life-cycle activities, and tracking/maintaining labeling documents.
• Ensure applicable global regulatory and compliance requirements are met and appropriately incorporated into all programs.
• Chair and drive label development for global labeling via the cross functional Label Working Group. Identify associated risks, develop risk mitigation strategies, and communicate project team decisions and project status. Apply influence and negotiation skills to support optimal label development.
• Oversee the prioritization, development, revision and approval of clinical supply labeling (e.g., active, placebos and standard of care drugs) in various countries to support the clinical pipeline.
• Serve as a strategic cross-functional partner collaborating with the CMO/CRO labeling specialists, and cross-functional project teams.
• Design, implement and maintain document tracking, history, versioning for labeling documents (including labeling project tracking tools and dashboards to monitor) and appropriate label archives across assigned projects and sites.
• Establish and maintain global strategic consistency across regional regulatory submissions.
• Oversight and accountability for labeling activities managed by external vendors, ensuring coordination and timely delivery.
• Present to cross-functional product teams and governance committees including executive level management to obtain endorsement, as appropriate, for the proposed labeling text.
• Ensure accurate and timely compilation and submission of all labeling documentation. Support responses to Health Authority queries related to labeling, including safety updates for approved labels.
• Create and maintain artwork for critical Regulatory functions: prepare labeling mock-ups for Health Authority submissions, manage expedited artwork approval process for US and ex-US market product.
• Lead the development of Standard Operating Procedures (SOPs) and process improvements for labeling generation and maintenance as needed to ensure high performing labeling operations and effective review processes.
• Staff and develop team members within global labeling regulatory.

Preferred Qualifications

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Strong professional experience in a similar role within the pharmaceutical industry, preferably small and large molecule pharmaceuticals, as well as combination products.
• Excellent collaboration skills with strong attention to detail and the ability to adapt to change, multi-task, prioritize, manage complexities, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent team management skills, ability to lead, train and mentor team members at all levels.
• Work independently with minimal supervision. Exercises judgment within defined practices and policies.
• Ability to travel 10-20% domestic and internationally.