Senior Regulatory Affairs Consultant – Regulatory Labeling Strategist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

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

🎯 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. • Fluency in English (verbal and written); additional languages would be an asset.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible working hours • Paid time off • Professional development opportunities