Associate Director, Global Regulatory Affairs Labeling in United States at Jobgether
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Job Description
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 the United States.
This role is a key global regulatory leadership position focused on shaping, developing, and maintaining labeling strategy across the lifecycle of innovative rare disease therapies. It plays a critical part in ensuring that product labeling is scientifically accurate, globally aligned, and fully compliant with evolving regulatory requirements across major markets. The position operates at the intersection of regulatory affairs, clinical development, safety, and commercial functions, translating complex regulatory inputs into clear, actionable labeling strategies. It also supports the development of core labeling documents and ensures consistency across global submissions and product lifecycle updates. The environment is highly cross-functional and matrixed, requiring strong collaboration with internal stakeholders and external partners. It is an ideal role for a regulatory expert who thrives in fast-paced, science-driven environments with global impact.
- Lead global labeling strategy in support of product development, regulatory submissions, and lifecycle management for rare disease therapies.
- Develop, revise, and maintain core labeling documents including CCDS, Prescribing Information, SmPC, Patient Information, and Instructions for Use.
- Drive target labeling strategy development in alignment with clinical, regulatory, and commercial objectives, including competitive landscape considerations.
- Collaborate across regulatory, clinical, safety, quality, legal, manufacturing, and commercial teams to ensure consistent and compliant labeling content.
- Lead Label Working Groups and Label Review Committees to resolve complex labeling issues and drive consensus across stakeholders.
- Manage global labeling changes through document management systems, ensuring accuracy, version control, and inspection readiness.
- Support health authority interactions by preparing labeling content for briefing books, submissions, and regulatory meetings (FDA, EMA, PMDA, and others).
- Ensure implementation of approved labeling across regions, maintaining alignment with global core labeling standards and local regulatory requirements.
- Oversee quality control processes across all stages of labeling development and ensure compliance with global regulatory guidelines.
Requirements:
- Bachelor’s degree in life sciences required; advanced degree preferred.
- 8+ years of experience in the pharmaceutical or biotechnology industry, including at least 4+ years in global regulatory affairs or labeling roles.
- Strong understanding of global drug development regulations and labeling requirements across major regulatory authorities.
- Proven experience developing and managing core labeling documents and leading cross-functional labeling processes.
- Strong ability to work in matrixed environments and influence cross-functional stakeholders without direct authority.
- Excellent attention to detail, organizational, and project management skills.
- Strong communication skills with the ability to present complex regulatory content clearly and effectively.
- Strategic thinker with strong problem-solving abilities and experience managing regulatory risks.
- Comfortable working in a fast-paced, evolving, and highly collaborative environment.
Benefits:
- Competitive base salary ranging from $178,100 to $220,000 annually, depending on experience and location.
- Eligibility for annual bonus and equity incentive programs.
- Generous vacation policy and company-recognized public holidays.
- Long-term incentive plans and employee stock purchase opportunities.
- Comprehensive health and employee wellbeing benefits.
- Fitness reimbursement and wellness support programs.
- Tuition assistance and professional development opportunities.
- Volunteer days and mission-driven, purpose-oriented work culture.