Senior / Regulatory Affairs Consultant - Labeling

Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets? Parexel is seeking an experienced and highly motivated Global Regulatory Labeling Lead to provide strategic leadership and operational oversight for complex global labeling initiatives. This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products across international markets. You will define labeling strategy, lead governance committees, and collaborate cross-functionally to deliver compliant, high-quality documentation throughout the product lifecycle.

Key Responsibilities

Strategic Labeling Leadership

• 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. Governance & Committee Leadership
• 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. Operational Oversight & Compliance
• 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. Global Implementation & Health Authority Engagement
• 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. Advertising, Promotion & Artwork
• 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. Special Projects
• 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. While candidates located in the EST time zon

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