Senior Regulatory Affairs Consultant – Labeling
Location
United States
Posted
87 days ago
Salary
Not specified
Bachelor Degree5 yrs expEnglishApollo
Job Description
• Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE).
• Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.
• Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership.
• Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities.
• Remain current with global labeling regulations and provide training to internal stakeholders.
• Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation.
• Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions.
• Support regional implementation of CDS updates and monitor compliance across markets.
• Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities.
Job Requirements
- Bachelor’s degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.
- 5-7 years in biotech/pharmaceutical industry; 2+ years in global labeling/regulatory with global strategic leadership responsibilities.
- Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
- Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
- Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations.
- Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).
- Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.
- Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred).
- Fluency in English (verbal and written); additional languages would be an asset.
Benefits
- Health insurance
- Flexible work arrangements
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