Labeling Strategist

Accountabilities • Lead and facilitate Labeling Working Groups and present labeling strategies, recommendations, and updates to cross-functional executive governance bodies.

• Lead the development, review, and maintenance of core labeling documents, including Core Data Sheets, core patient information leaflets, and core instructions for use.

• Oversee regional and U.S. labeling deliverables, including prescribing information, patient labeling, and medication guides.

• Represent labeling on product-specific global regulatory teams and provide guidance on regulatory decisions that may affect assigned products and portfolios.

• Develop and provide strategic input into Target Product Labeling and broader global regulatory labeling strategies.

• Manage labeling activities for products with moderate to high levels of complexity throughout their development and commercialization life cycles.

• Provide strategic guidance on labeling regulations, requirements, competitor labeling, and emerging labeling trends to regulatory colleagues and cross-functional stakeholders.

• Advise internal and external subject-matter experts on the development of high-quality documents supporting changes to core labeling and manage document annotations.

• Provide strategic labeling advice across major regions and collaborate with cross-functional teams to ensure global regulatory labeling plans align with overall regulatory strategies.

• Review, provide feedback on, and approve appropriate deviations from core labeling while ensuring deviations from established procedures and policies are escalated appropriately.

• Support the preparation of responses to labeling-related Health Authority questions and manage the review and approval of core Dear Healthcare Professional (DHCP) letters.

• Contribute labeling expertise to annual reports, DSURs, PBRERs, product quality complaint reviews, and other regulatory activities.

• Identify labeling challenges and collaborate with stakeholders to develop practical, compliant, and sustainable solutions.

• Supervise direct reports where applicable and support their professional development and career growth.

• Manage multiple projects, assignments, and regulatory timelines while maintaining strong attention to detail and quality.

• Travel approximately 10% as needed for business requirements, meetings, or other activities.

Requirements

• Doctorate degree plus 2 years of related experience, or master’s degree plus 4 years, or bachelor’s degree plus 6 years, or associate’s degree plus 10 years, or high school diploma/GED plus 12 years of related experience.

• Degree in life sciences or medicine preferred.

• Significant experience in pharmaceutical Regulatory Affairs and/or product labeling.

• Demonstrated expertise in product labeling within a relevant therapeutic area.

• Strong knowledge of global labeling regulations, standards, and processes, including familiarity with FDA, EMA, and other international regulatory requirements.

• Comprehensive understanding of product development and relevant biology and pharmacology within the applicable therapeutic area.

• Extensive knowledge of regulatory affairs concepts, procedures, practices, and industry standards.

• Strong project management capabilities, including experience planning, coordinating, implementing, and delivering complex, timeline-driven regulatory activities.

• Experience managing individual and cross-functional projects of moderate to high complexity.

• Demonstrated ability to develop independent solutions that are thorough, practical, and aligned with functional objectives.

• Strong analytical thinking, critical judgment, decision-making, and problem-solving skills.

• Demonstrated ability to lead teams, influence stakeholders, resolve conflicts, and negotiate effectively.

• Excellent technical writing, presentation, verbal, and written communication skills.

• Strong interpersonal, organizational, and collaboration skills.

• High attention to detail and ability to manage multiple priorities and deadlines simultaneously.

• Experience working with Regulatory Information Management systems.

• Familiarity with Veeva- or Documentum-based document management systems preferred.

• Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.

• Ability to work effectively in a remote, cross-functional, and globally distributed environment.

Benefits

• Annual salary range of $132,972.30–$179,903.70 for eligible U.S. locations, excluding Puerto Rico; actual compensation varies based on skills, experience, qualifications, and other relevant factors.

• Comprehensive health and welfare benefits for eligible employees and dependents.

• Medical, dental, and vision coverage.

• Retirement and savings plan with company contributions.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentive opportunities.

• Generous paid time-off programs.

• Flexible work models where applicable.

• Career development and professional growth opportunities.

• Opportunity to work on global pharmaceutical labeling strategy and products addressing significant medical needs.

• Collaborative, science-driven environment with cross-functional and international exposure.

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