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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