Senior Regulatory Affairs Consultant – Regulatory Labeling Strategist

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish and steer the global labeling strategy across both foundational and non-foundational markets (US, EU, AU, CH, DE).

• Lead the development, revision, and oversight of essential labeling documents, which include the Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.

• Ensure alignment of labeling content and strategy among U.S., EU, and global regulatory teams; facilitate prompt endorsement of labeling decisions by senior leadership.

• Analyze clinical and scientific data to guide labeling content and product claims; identify strategic risks and opportunities.

• Stay updated on global labeling regulations and provide training to internal stakeholders.

• Chair and manage the Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation.

• Oversee operational labeling tasks, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions.

• Assist in the regional implementation of CDS updates and monitor compliance across various markets.

• Review and authorize direct-to-consumer and marketing advertising, medical education, and social media content for regulatory compliance.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related field; advanced degree (MSc, PhD, PharmD) is preferred.

• 5-7 years of experience in the biotech/pharmaceutical industry; at least 2 years in global labeling/regulatory with strategic leadership responsibilities.

• Demonstrated ability to lead cross-functional teams and influence stakeholders across a variety of cultural and geographic contexts.

• In-depth knowledge of the regulatory labeling lifecycle management in the US, EU, DE, CH, and AU.

• Experience with direct-to-consumer advertising, social media review, and negotiations with Health Authorities.

• Familiarity and capability to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).

• Proficiency in Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.

• Fluent in English (both verbal and written); knowledge of additional languages is a plus.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible working hours

• Paid time off

• Professional development opportunities