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

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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 • Lead creation, revision, and management of core labeling documents, including CDS, USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile • Align labeling content and strategy across U.S., EU, and global regulatory teams • Interpret clinical and scientific data to inform labeling content and product claims • Maintain current knowledge of global labeling regulations and provide stakeholder training • Chair and manage Labeling Review Committee, Global Labeling Committee, and CCDS Working Team • Develop and maintain governance frameworks for company labeling positions and foundational markets • Oversee operational labeling activities, artwork coordination, linguistic reviews, and U.S. SPL submissions • Maintain labeling documentation in eDMS and regulatory tracking platforms, ensuring version control, SOP adherence, and audit readiness • Manage change control documentation, specimen requests, and part-number verification • Ensure FDA Section 508 accessibility compliance on U.S. labels • Support regional implementation of CDS updates and monitor compliance across markets • Address Health Authority inquiries and manage country-specific labeling variations • Prepare RFIs, differences tracking tables, and lead Health Authority negotiations • Review and approve 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 and devices • Lead annual strain updates for Northern and Southern Hemisphere flu campaigns • Manage labeling for U.S. Drug Listing Reports, including NDC assignments and annual reporting

🎯 Requirements

• Bachelor’s degree in Life Sciences or related field • 5–7 years in the 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, and AU regulatory labeling lifecycle management • Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations • Familiarity with RIMS, such as Veeva RIMS; eDMS, such as Veeva; Apollo; Docubridge; and change management systems, such as Trackwise • Experience with Microsoft Office, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS • Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing • Demonstrated problem-solving, risk analysis, and sound decision-making • Strong collaboration skills in global, cross-cultural, matrix environments • Strong organizational and communication skills • Proficient regulatory knowledge, including scientific concepts within labeling and their global implications • Attention to detail with strategic thinking • Fluency in English, verbal and written • Candidates outside EST must be flexible to provide coverage during EST hours • Advanced degree (MSc, PhD, PharmD) preferred

🏖️ Benefits

• Opportunity to shape global labeling strategy and lead governance processes • Dynamic, collaborative environment • Equal opportunity employer • Work remotely within the United States