Associate Director, Regulatory Affairs – Global Labeling Strategy Lead
Job ID: 293122 | Location: Billerica, Massachusetts, United States (Hybrid) | Job Type: Full-Time
Position Overview
EMD Serono is seeking an accomplished Associate Director, Global Labeling Strategy Lead to provide strategic oversight of regulatory labeling for prescription drug products. This role ensures global consistency, compliance, and alignment with company objectives while leading cross-functional labeling initiatives. The ideal candidate will have extensive experience in US and EU regulatory labeling, as well as expertise in managing global labeling documents and regulatory authority interactions.
Note: This position does not offer sponsorship; candidates must be authorized to work in the U.S.
Key Responsibilities
Lead the creation and maintenance of Company Core Data Sheets (CCDS) to ensure harmonized labeling across global markets.
Manage US and EU product information (PIs) and global packaging text, ensuring consistency with CCDS and compliance with regulatory standards.
Oversee cross-functional labeling teams, prepare proposals for the Labeling Senior Management Board, and secure internal approvals for labeling content.
Support country regulatory teams in developing local PIs and ensure accurate implementation of CCDS content.
Coordinate and respond to labeling inquiries from health authorities and participate in regulatory negotiations.
Develop target product labeling for pipeline products, as needed, including competitive labeling analysis and monitoring evolving regulatory requirements.
Contribute to labeling-related SOPs, guidelines, and company-wide initiatives to enhance labeling compliance and efficiency.
Train product labeling teams and mentor labeling experts on lifecycle management and regulatory best practices.
Cultivate relationships with regulatory authorities, professional associations, and industry stakeholders to ensure alignment on global labeling strategies.
Candidate Profile
Minimum Qualifications
Bachelor’s degree in science or health-related discipline. Advanced degrees (PhD, MD, MS, PharmD, MBA) preferred.
5+ years of pharmaceutical industry experience, including 3+ years in Regulatory Affairs Labeling.
Deep knowledge of US and EU regulatory labeling requirements and life-cycle management.
Strong proficiency in MS Office (Word, Excel, PowerPoint, Project), SharePoint, and regulatory systems (e.g., EDMS).
Excellent attention to detail, with the ability to review regulatory documents for accuracy, consistency, and compliance.
Strong written and oral communication skills.
Preferred Qualifications
10+ years of pharmaceutical industry experience, with 5+ years in Regulatory Affairs Labeling.
Knowledge of global labeling regulations including markets such as Japan and China.
Experience in global drug development and lifecycle management regulations.
Demonstrated leadership in cross-functional projects and regulatory strategy implementation.
Compensation & Benefits
Base Salary Range: USD 132,700 – 199,100 (actual compensation will be based on experience, education, location, and other job-related factors)
Eligible for performance-based bonuses.
Comprehensive benefits including health insurance, paid time off (PTO), retirement contributions, and additional perks.
Why Join EMD Serono?
At EMD Serono, we believe that diversity of thought, experience, and background drives innovation and excellence. Our inclusive culture empowers employees to grow, develop, and make meaningful contributions to healthcare. Join our team to lead global labeling strategies that impact patient safety, regulatory compliance, and product success worldwide.
Apply Today
Take the next step in your Regulatory Affairs career and become a key contributor to EMD Serono’s global labeling initiatives, ensuring safe, compliant, and strategically aligned product information across markets.
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