Associate Director Global Regulatory Affairs

SSi People; Cambridge (MA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

SSi People seeks an Associate Director Global Regulatory Affairs in Cambridge, MA, offering a hybrid work model. This role focuses on global labeling strategy and lifecycle management for pharmaceutical drug and device products, driving strategic regulatory insights and collaboration across functions.

The position leads CCDS, USPI, and EU SmPC labeling efforts, guides internal stakeholders, and ensures compliant labeling processes across regions.

Qualifications

• 7-10 years of experience in the biopharmaceutical industry.
• 5-7 years of direct experience in a global, US, or EU labeling role.
• Bachelor’s or Master’s degree required.
• Detailed understanding of pharmaceutical drug and device development and global labeling regulations, including EU and US requirements and guidance.
• Experience with CCDS, USPI, and EU SmPC development and maintenance.
• Proficiency in Electronic Document Management Systems and End-to-End labeling tracking systems.

Responsibilities

• Lead development and lifecycle management of CCDS, US, and EU labeling strategy.
• Provide regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders.
• Drive labeling reviews, resolve issues, prepare backup strategies, and support negotiations with health authorities.
• Manage labeling processes, documentation, version control, QC, tracking, and training to support compliance and consistency.

Skills

Regulatory affairs

Labeling strategy

Cross-functional collaboration

US/EU labeling knowledge

Education

Bachelor's degree

Master's degree

Tools

Electronic Document Management Systems

End-to-End labeling tracking systems

Job description

Job Title: Associate Director Global Regulatory Affairs

Location: Cambridge, Massachusetts (Hybrid)

Job Summary: We are seeking an experienced regulatory professional to support global labeling strategy and lifecycle management for pharmaceutical drug and device products within a complex, cross-functional environment. Our team is looking for someone who can bring strategic insight, sound judgment, and strong collaboration skills to help shape labeling decisions that support development, commercialization, and ongoing maintenance.

Responsibilities

• Lead development and lifecycle management of CCDS, US, and EU labeling strategy.
• Provide regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders.
• Drive labeling reviews, resolve issues, prepare backup strategies, and support negotiations with health authorities.
• Manage labeling processes, documentation, version control, QC, tracking, and training to support compliance and consistency.

Required

• 7-10 years of experience in the biopharmaceutical industry.
• 5-7 years of direct experience in a global, US, or EU labeling role.
• Bachelor’s or Master’s degree required.
• Detailed understanding of pharmaceutical drug and device development and global labeling regulations, including EU and US requirements and guidance.
• Experience with CCDS, USPI, and EU SmPC development and maintenance.
• Proficiency in Electronic Document Management Systems and End-to-End labeling tracking systems.

About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.