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Job description
Job Title: Associate Director, Global RA Labeling Lead
Location: Cambridge, MA- Hybdrid
Pay Rate: $134.90–$139.55/hr.
Duration: 7 months
Job Description
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.
Education
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.
Required Skills
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
Preferred Skills
Plasma-derived therapies (PDT) and biologics
Advertising and promotion regulations
Global drug development and regulatory strategy
Labeling process, template, tool, and system optimizationExperience managing direct reports and global labeling teams
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.