Associate Director, Regulatory Affairs – Global Labeling Strategy Lead
Location: Billerica, Massachusetts, USA
Job Type: Full-Time
Company: EMD Serono
About the Role
EMD Serono is seeking an accomplished Associate Director, Regulatory Affairs – Global Labeling Strategy Lead to oversee global labeling strategies, ensure regulatory compliance, and support worldwide product lifecycle management. This leadership role is critical in driving the development, maintenance, and harmonization of global labeling content, including Company Core Data Sheets (CCDS), US and EU Product Information (PI), and global packaging components.
This position requires strong expertise in regulatory labeling, cross-functional leadership, and the ability to support international teams across multiple regions.
Note: This role does not offer work authorization sponsorship. Applicants must be eligible to work in the United States.
Key Responsibilities
Lead the development, revision, and maintenance of global Company Core Data Sheets (CCDS) in collaboration with cross-functional product teams.
Manage US/EU Product Information (PI) creation, updates, reviews, and internal approvals, ensuring full alignment with CCDS.
Oversee the integration of CCDS content into country-specific labeling and provide strategic support to regional regulatory teams.
Serve as the subject matter expert for labeling-related regulatory authority queries and participate in regulatory negotiations when required.
Lead and coordinate global labeling governance activities, including presenting proposals to senior labeling management boards.
Develop labeling strategy and target product labeling content for pipeline and development-stage products.
Conduct competitive labeling assessments and maintain up-to-date knowledge of international labeling regulations.
Contribute to labeling process improvements, internal guidelines, and regulatory initiative reviews.
Train and mentor labeling team members and foster collaboration with industry associations, global regulatory authorities, and cross-functional partners.
Required Experience & Qualifications
Bachelor’s degree in a science, pharmacy, or health-related field.
Minimum 5+ years of pharmaceutical industry experience, including 3+ years in Regulatory Affairs Labeling.
Strong understanding of US and EU labeling regulations, standards, and lifecycle management practices.
Proven experience in reviewing regulatory documentation for accuracy, consistency, and compliance.
High-level proficiency in MS Office tools, SharePoint, and regulatory document systems (EDMS).
Excellent communication, analytical, and documentation skills.
Preferred Qualifications
Advanced degree (PhD, MD, MS, PharmD, MBA).
10+ years pharmaceutical industry experience with 5+ years in global regulatory labeling.
Experience with labeling requirements in Japan, China, and other global markets.
Knowledge of global drug development and regulatory lifecycle management.
Work Arrangement
Location: Billerica, MA (Hybrid Work Model)
Compensation & Benefits
Base Salary Range: USD $132,700 – $199,100 (depending on experience, skills, location, and qualifications)
Eligible for performance-based incentives
Comprehensive benefits package including:
Health insurance
Paid time off (PTO)
Retirement plan contributions
Additional company benefits and employee programs
Why Join EMD Serono?
At EMD Serono, we foster an inclusive and globally collaborative environment that supports innovation, continuous learning, and scientific excellence. Our teams work across continents to deliver meaningful healthcare solutions in fields such as oncology, neurology, and fertility. We are committed to developing talent, driving diversity, and empowering individuals to achieve professional growth while making an impact on patients worldwide.
Apply Now
If you are a regulatory labeling professional seeking a global role with significant strategic influence, we invite you to apply and contribute to advancing innovative healthcare solutions.
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