Labeling Strategist

Overview

Lead global labeling strategy and manage end-to-end labeling processes for pre- and post-market products across their life cycles. Develop and maintain core and regional labeling documents for assigned therapeutic areas.

What you'll do

• Lead Labeling Working Groups and present to executive labeling boards.
• Develop and maintain core labeling documents and US labeling deliverables.
• Represent labeling on product-specific global regulatory teams.
• Provide strategic guidance on target product labeling, regulations, requirements, and trends.
• Manage labeling for compounds with medium to high complexity.
• Review deviations, support Health Authority responses, and manage DHCP letter approvals.
• Supervise direct reports and support their career development, if applicable.

What you'll need

• Doctorate with 2 years, master's with 4 years, bachelor's with 6 years, associate's with 10 years, or high school diploma/GED with 12 years of related experience.
• Extensive regulatory affairs knowledge and familiarity with regulatory concepts, procedures, practices, and industry standards.
• Knowledge of global labeling regulatory requirements, standards, and processes.
• Understanding of product development, biology, and pharmacology relevant to the therapeutic area.
• Strong project management, technical writing, communication, leadership, negotiation, and conflict-resolution skills.
• Experience with a Regulatory Information Management system and proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
• Ability to lead teams and manage multiple timeline-driven assignments.

Nice to have

• Degree in life science or medicine.
• Pharmaceutical industry regulatory affairs or product labeling experience.
• Knowledge of FDA, EMA, and other international labeling regulations.
• Experience with Veeva or Documentum-based document management systems.

Details

• Remote in the United States.
• Travel required up to 10% as needed.
• Expected annual salary: USD 132,972.30–179,903.70.