Associate Director Global Regulatory Affairs

Job Title: Associate Director, Global RA Labeling Lead
Location: Cambridge, MA
- Hybdrid
Pay Rate: $134.90–$139.55/hr.
Duration: 7 months

• Lead global regulatory labeling strategy and lifecycle management for plasma-derived therapies (PDT), including CCDS, USPI, and EU SmPC.
• Develop and implement labeling strategies for developmental and marketed products across US, EU, and international markets.
• Lead global labeling teams and cross-functional labeling projects, including preparation, review, approval, and maintenance of submission-ready labeling.
• Interpret clinical, scientific, medical, safety, and regulatory data to develop compliant labeling and support benefit-risk assessments.
• Provide regulatory guidance on pharmaceutical drug and combination product/drug-device labeling requirements.
• Apply Health Authority feedback, labeling precedent, regulatory intelligence, and applicable guidance to support labeling negotiations and strategy.
• Manage labeling processes, templates, tools, version control, QC, decision records, and end-to-end labeling tracking.
• Support regulatory affiliates with assessment and implementation of labeling changes and Health Authority communications.
• Develop and deliver regulatory labeling training and ensure adherence to global labeling procedures and compliance requirements.

• Bachelor’s or Master’s degree required.
• Advanced scientific or health sciences degree preferred.
• 7–10+ years of experience in the biopharmaceutical industry, with 5–7+ years of direct experience in global, US, or EU regulatory labeling preferred.

• Global Regulatory Labeling Strategy
• CCDS, USPI, and EU SmPC development and lifecycle management
• US and EU pharmaceutical labeling regulations and Health Authority guidance
• Regulatory labeling for pharmaceutical drugs and drug-device/combination products
• SPL format, legacy labeling, and PLR labeling requirements
• Regulatory submission-ready labeling and Health Authority labeling negotiations
• Electronic Document Management Systems (EDMS)
• End-to-End (E2E) Labeling Tracking Systems
• Labeling document QC and version control
• Regulatory Intelligence and labeling precedent assessment

• Plasma-derived therapies (PDT) and biologics
• Advertising and promotion regulations
• Global drug development and regulatory strategy
• Labeling process, template, tool, and system optimization
  
  Experience managing direct reports and global labeling teams

#LI-BS1