Senior Director, Regulatory Affairs – Head of Global Labeling and Labeling Operations

This is a fully remote position, open to applicants in United States, +2 more countries.

📋 Description

• Define the global vision, priorities, and strategy for labeling across both development-stage and marketed products.

• Act as the senior regulatory authority for labeling strategy and lead the preparation and execution of FDA labeling negotiations.

• Integrate labeling strategies with the global regulatory strategy, clinical development, safety evaluation, commercialization, and lifecycle planning.

• Provide senior leadership with insights on labeling opportunities, evidence requirements, regulatory risks, and negotiation trade-offs.

• Build and nurture a high-performing global labeling organization.

• Oversee the development and maintenance of CCDS, USPI, and EU product information.

• Establish scientifically substantiated labeling positions for registrations, new indications, formulations, patient populations, safety updates, and lifecycle changes.

• Provide strategic oversight for regional and country labeling.

• Collaborate with Safety on emerging information and timely labeling updates.

• Partner with Advertising, Promotion, and Strategic Commercialization on approved labeling and compliant claims.

• Lead the labeling strategy throughout development, registration, and post-approval lifecycle management.

• Offer guidance on indication wording, patient populations, dosing, limitations of use, safety information, and clinical study results.

• Develop labeling negotiation strategies and advise senior leadership on potential outcomes.

• Monitor labeling precedents, competitor labels, and evolving regulatory expectations.

• Implement and refine the Target Product Label process.

• Enhance the internal Label Working Group and Global Labeling Committee.

• Drive evidence-based resolution of differing viewpoints and escalate strategic issues as needed.

• Provide training and guidance to enhance labeling capabilities.

• Manage internal FTEs, consultants, and external service providers.

• Set objectives, responsibilities, performance expectations, and resource alignment.

• Mentor and coach team members while supporting career development and succession planning.

• Manage consultant scope, deliverables, quality, performance, and knowledge transfer.

• Advance labeling processes, systems, standards, and interfaces with related functions.

• Oversee capacity planning, budgets, vendor performance, labeling compliance, and readiness for inspections.

⛳️ Requirements

• Ideally, a minimum of 15 years of relevant experience in the biopharmaceutical industry.

• At least 7 years dedicated to labeling strategy.

• An advanced scientific or clinical degree is preferred.

• Extensive, hands-on expertise in global labeling strategy throughout development, registration, and post-approval lifecycle management.

• Proven experience leading FDA labeling negotiations for original NDA/BLA approvals and/or major supplemental indications.

• Demonstrated ability to interpret clinical efficacy and safety evidence, translating it into defensible labeling positions and successful negotiation strategies.

• Experience in developing and maintaining TPLs, CCDS, USPI, and EU product information.

• Strong understanding of FDA labeling requirements and expectations, alongside working knowledge of EU and other major-market labeling requirements.

• Demonstrated experience in implementing or evolving a TPL process and strengthening cross-functional labeling governance.

• Proven leadership experience in managing and developing internal FTEs, overseeing consultants, and operating effectively within a highly matrixed environment.

• Experience in building or evolving a labeling function within a rapidly growing biopharmaceutical organization is desirable.

• Experience in supporting product launches and major lifecycle milestones; expertise in biologics, specialty, or rare diseases is a plus.

• Excellent executive communication, negotiation, presentation, and cross-functional influencing skills.

• Strong leadership capabilities demonstrated by a proven ability to build, motivate, mentor, and develop a team.

• Candidates must be located in the US (EST time zone), Belgium, or Switzerland to be considered for this position.

🏝️ Benefits

• Short-term incentive programs.

• Long-term incentive programs.

• Retirement savings plans.

• Health benefits.

• Comprehensive benefits package.