Global Regulatory Labeling Lead — Associate Director

Pharmaceutical Company; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Pharmaceutical Company in Cambridge, MA seeks an Associate Director, Global Regulatory Affairs Labeling Lead to drive global labeling strategy for Plasma-Derived Therapies. You will own CCDS, USPI, and EU SmPC lifecycle, influence senior stakeholders, and coordinate with regulatory, clinical, pharmacovigilance, and cross-functional teams to ensure compliant, market-ready labeling across regions. This role requires strong regulatory leadership and a track record of global labeling excellence.

Qualifications

• Bachelor’s or Master’s degree in a scientific, health sciences, pharmaceutical, or related discipline.
• 7–10+ years in biopharmaceutical/pharmaceutical industry.
• 5–7+ years in global, US, or EU regulatory labeling.
• Experience developing CCDS, USPI, and EU SmPC lifecycle
• Strong understanding of US/EU labeling regulations and guidance.

Responsibilities

• Lead global labeling strategy and lifecycle management for PDT products.
• Develop and maintain CCDS, USPI, and EU SmPC.
• Offer strategic labeling input to regulatory strategies and negotiations.
• Lead global CCDS, US, and EU labeling teams.
• Guide regional affiliates in labeling changes and timelines.
• Ensure QC, version control, and archival of labeling materials.

Skills

Cross-functional leadership

Stakeholder management

Regulatory strategy

Labeling expertise

Regulatory judgment

Education

Bachelor’s or Master’s in a scientific/health discipline

Job description

Pharmaceutical Company in Cambridge, MA seeks an Associate Director, Global Regulatory Affairs Labeling Lead to drive global labeling strategy for Plasma-Derived Therapies. You will own CCDS, USPI, and EU SmPC lifecycle, influence senior stakeholders, and coordinate with regulatory, clinical, pharmacovigilance, and cross-functional teams to ensure compliant, market-ready labeling across regions. This role requires strong regulatory leadership and a track record of global labeling excellence.