Sr. Director, Global Regulatory Affairs Labeling

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr. Director, Global Regulatory Affairs Labeling in United States.

This senior leadership role sits at the center of global regulatory strategy, responsible for defining and executing end-to-end labeling strategy across a diverse rare disease portfolio. You will lead the development of critical labeling components from early clinical stages through commercialization, ensuring compliance across US and EU regulatory frameworks. The position requires close collaboration with regulatory, clinical, development, and commercial teams to align labeling strategy with broader program objectives. You will oversee both strategic labeling leads and operational labeling teams, driving consistency, quality, and regulatory excellence. This is a highly visible role with direct influence on global product lifecycle decisions and health authority submissions. Operating in a mission-driven environment, you will help shape how innovative therapies reach patients worldwide.

Accountabilities:

• Lead the global labeling function and serve as the internal expert on labeling regulations, guidance, and health authority expectations across major markets.
• Own the end-to-end labeling strategy for all programs from development through commercialization, ensuring regulatory compliance and strategic alignment.
• Oversee the creation, review, and approval of all labeling components, including prescribing information, package inserts, CCDS, and packaging artwork.
• Develop and author labeling text supporting regulatory submissions and lifecycle updates across US, EU, and other global regions.
• Ensure labeling strategies are fully aligned with broader regulatory and program objectives through close cross-functional collaboration.
• Chair labeling governance forums and drive senior-level alignment and approval of labeling content and strategy.
• Lead, mentor, and develop global teams responsible for labeling strategy and labeling operations, including packaging and artwork oversight.
• Provide expert guidance on evolving regulatory requirements, tools, and global labeling best practices.
• Ensure consistency, compliance, and quality across all labeling deliverables throughout the product lifecycle.

Requirements:

• Advanced degree in life sciences (PhD, PharmD, or MSc preferred) with a strong scientific foundation.
• 12+ years of experience in biotechnology or pharmaceutical industries with deep global labeling expertise.
• Strong background in regulatory affairs, development, and/or post-marketing activities across US and EU markets.
• Proven expertise in global labeling processes, including strategy development and operational execution.
• Excellent scientific writing skills with the ability to translate complex data into clear, compliant labeling content.
• Strong leadership capabilities with experience managing and developing high-performing teams in matrix organizations.
• Demonstrated ability to make sound decisions in complex, ambiguous regulatory environments.
• Strong communication, negotiation, and stakeholder management skills.
• Strategic thinker with the ability to balance regulatory requirements with business objectives.
• Collaborative mindset with the ability to influence across cross-functional and global teams.
• Rare disease or specialty pharma experience is a plus.

Benefits:

• Competitive annual salary range of $243,800 to $301,100 USD.
• Eligibility for annual bonus and long-term equity incentive programs.
• Generous vacation policy and company-recognized public holidays.
• Employee stock purchase plans or equivalent equity participation options.
• Comprehensive wellbeing programs supporting physical and mental health.
• Fitness reimbursement and wellness-related benefits.
• Tuition assistance and professional development support.
• Volunteer days and additional paid time off for community engagement.
• Remote-first work model with flexibility and global collaboration opportunitie

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1