Associate Director, Global Regulatory Affairs Labeling in United States at Jobgether

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

This is a high-impact regulatory leadership role focused on global labeling strategy across the full product lifecycle for innovative therapies in rare diseases. You will act as a key expert guiding labeling development from clinical stages through commercialization and post-approval changes. The role sits at the intersection of regulatory affairs, clinical development, safety, and commercial strategy, ensuring consistency across global product information. You will shape target product labeling strategies and help align cross-functional stakeholders around regulatory expectations and business objectives. Working in a fast-paced, matrixed environment, you will collaborate with global teams and health authorities across major markets. This position is remote with occasional travel and offers the opportunity to influence critical patient-facing documentation worldwide.

In this role, you will lead global labeling strategy and execution across development and lifecycle programs while ensuring regulatory compliance and alignment with business objectives:

• Define and drive global labeling strategies, including target label development and alignment with clinical and regulatory program goals
• Develop and maintain core labeling documents such as CCDS, prescribing information, SmPCs, patient leaflets, and instructions for use
• Lead cross-functional labeling activities and facilitate alignment across Regulatory, Clinical, Safety, Medical Affairs, Legal, Quality, and Commercial teams
• Manage labeling changes across product lifecycle, ensuring timely implementation and global consistency across markets
• Coordinate Label Working Group and Label Review Committee activities, driving consensus on complex labeling issues
• Prepare regulatory documentation supporting submissions, health authority interactions, and approval milestones
• Oversee labeling compliance, quality control, document management, translation verification, and artwork review
• Contribute to process improvements, governance frameworks, and labeling system enhancements

The ideal candidate brings deep regulatory labeling expertise within biotech or pharmaceutical environments, combined with strong leadership and cross-functional influence:

• Bachelor’s degree in life sciences required; advanced degree preferred
• 8+ years of experience in biotech or pharmaceutical industry, including 4+ years in global regulatory labeling roles
• Strong understanding of global drug development regulations and labeling requirements across major health authorities
• Proven experience developing and managing global labeling content across multiple markets
• Strong cross-functional leadership skills with ability to influence in a matrix environment
• Excellent communication, stakeholder management, and negotiation abilities
• Strong analytical mindset with attention to detail and ability to manage multiple priorities
• Experience working in fast-paced, evolving environments with ambiguity and changing priorities

• Competitive base salary with eligibility for annual bonus and equity incentives
• Remote-first work model with occasional travel as needed
• Generous paid vacation, holidays, and volunteer days
• Long-term incentive programs and employee stock purchase opportunities
• Comprehensive wellbeing benefits and fitness reimbursement programs
• Tuition assistance and continuous professional development support
• Employee assistance and wellness resources
• Inclusive and flexible work environment supporting work-life balance