This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Global Labeling Lead in the United States.
This senior regulatory leadership role sits at the intersection of global strategy, science, and compliance, shaping how critical medicinal product information is developed and maintained across global markets. You will lead end-to-end labeling strategy for commercial products, ensuring alignment across key regulatory documents such as core data sheets and regional prescribing information. Operating in a highly cross-functional and globally visible environment, you will collaborate with regulatory, clinical, and commercial experts to ensure accurate, timely, and compliant product communication. The role requires strong strategic thinking, deep regulatory expertise, and the ability to influence across global teams. You will also play a key role in building and improving labeling systems, processes, and governance frameworks. This is a high-impact position contributing directly to how innovative therapies reach patients worldwide.
Accountabilities
In this role, you will define and lead global labeling strategy while ensuring compliant, consistent, and timely product information across all regulatory markets.
- Define and execute global labeling strategy for lifecycle management of medicinal products, including core data sheets and regional prescribing information
- Lead cross-functional labeling teams and coordinate stakeholders across regulatory, clinical, and commercial functions
- Oversee timely preparation and updates of labeling documents in response to regulatory changes and health authority requirements
- Ensure alignment and communication of updated labeling content across global and local markets
- Develop, improve, and maintain global labeling processes, systems, and governance frameworks
- Identify and resolve critical labeling issues in collaboration with internal and external stakeholders
- Act as delegated representative for global labeling leadership when required
Requirements
This role requires deep regulatory affairs expertise with strong experience in global labeling strategy and lifecycle management in a complex, international environment.
- Degree in pharmacy, biology, chemistry, biochemistry, medicine, or related scientific field (advanced degree preferred)
- 9–16 years of experience in global regulatory affairs, ideally in biologics, vaccines, or pharmaceuticals
- Strong hands-on experience developing and maintaining prescribing information (CCDS, USPI, EU SmPC)
- In-depth knowledge of FDA and EMA regulatory requirements related to labeling and product information
- Proven ability to lead complex, cross-functional global projects with minimal supervision
- Strong strategic thinking combined with attention to regulatory detail and compliance
- Excellent written and verbal communication skills in English
- Ability to influence stakeholders and operate effectively in a global matrix environment
Benefits
- Competitive base salary range: $146,300 – $234,100/year
- Annual bonus and equity opportunities (performance-based)
- Comprehensive medical, dental, and vision insurance
- Life, AD&D, and critical illness coverage
- 401(k) plan with company match
- Generous paid time off including vacation, sick leave, holidays, and year-end shutdown
- Parental leave, family planning support, and childcare resources
- Tuition reimbursement and student loan assistance programs
- Wellbeing incentives and employee assistance programs
- Professional development and career growth opportunities
- Additional perks including commuting support and insurance discounts
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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