Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist

Key Responsibilities

• 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.
• Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets.
• Influence external labeling landscape through policy intelligence and strategic engagement.
• Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions.
• Maintain labeling documentation within eDMS and regulatory tracking platforms; ensure robust version control and SOP adherence for audit readiness.
• Manage change control documentation, specimen requests, and verify part numbers for correct submissions.
• Ensure FDA Section 508 accessibility compliance on U.S. labels.
• Support regional implementation of CDS updates and monitor compliance across markets.
• Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations.
• Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities.
• Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance.
• Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs; oversee mock-ups and production for combination products/devices.
• Lead annual strain updates for Northern/Southern Hemisphere flu campaigns.
• Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting.

Qualifications

• Education: Bachelor’s degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.
• Experience: 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.
• Technical Expertise: 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.
• Core Competencies: Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred); demonstrated problem-solving ability with risk analysis and sound decision-making; strong collaboration skills, with experience working in global, cross-cultural, matrix environments; organizational skills to interact seamlessly both internally and externally on compliance matters; proficient regulatory knowledge, including scientific concepts within labeling and their global implications; effective communication skills for explaining concepts, options, and impacts; attention to detail with the ability to think strategically; Fluency in English (verbal and written); additional languages would be an asset.