Associate Director, Global Regulatory Affairs Labeling [Remote]

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.

Accountabilities

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

Requirements

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

Benefits

• 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

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!

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.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.