Senior Global Regulatory Labeling Strategist

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Provide strategic leadership and operational oversight for global labeling activities • Lead Target Product Label (TPL) development for early-stage assets • Develop and maintain Company Core Data Sheets (CCDS) • Develop regional labeling strategies and support US, EU, Rest of World, and other major markets • Develop labeling content, format, and accountability for regulatory submissions, including MAAs, supplements, and amendments • Ensure new labeling text meets regulatory labeling requirements • Support Rest of World labeling assessments against the CCDS and prepare Health Authority responses • Interface with project teams to ensure consistent labeling processes and local compliance with the CCDS • Communicate regulatory labeling strategy, risks, mitigation strategies, and plans to global leadership, project development teams, and senior management • Provide input into the end-to-end labeling process • Lead and manage labeling team meetings, driving strategic discussions and managing content • Provide coverage for other products during peak periods or team-member absences • Partner with stakeholders across Regulatory, Clinical, Safety, Medical, and Commercial functions • Contribute to medical and technical writing, ROW impact assessments, and cross-functional product-development decisions • Ensure compliant, high-quality labeling documentation throughout the product lifecycle

🎯 Requirements

• Bachelor’s degree in Life Sciences or related field required • Advanced degree (MSc, PhD, PharmD) preferred • 7-10+ years in biotech/pharmaceutical industry • 5-7+ 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 current global regulations, including vaccine development regulations and registration pathways • Previous experience in oncology or rare disease highly preferred • Strong experience with CTD format and content regulatory filings • Direct experience authoring, maintaining, and governing CCDS required, including ownership of global labeling updates and coordination of downstream implementation across regional labels • Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.) • Familiarity 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 • Experience facilitating meetings and driving consensus and results • Excellent leadership, communication (verbal and written), and collaboration skills • Proven ability in medical/technical writing • Experience with TPL work for early development programs and identified life-cycle programs • Sense of urgency regarding FDA/EMA/MHRA/other health authority communications and response timelines • Integrity and high standards • Results orientation and strategic orientation • Flexibility/adaptability in varied situations and with diverse individuals and groups • Relationship building, teamwork, and cooperation • Fluency in English (verbal and written); additional languages are an asset • Candidates outside the EST time zone must have flexibility to provide coverage during EST hours

🏖️ Benefits

• Equal opportunity employment consideration • Opportunity to work across diverse markets and therapeutic areas • Opportunity to shape global labeling strategy and lead governance processes • Collaborative, dynamic environment • Opportunity to contribute to innovative campaigns and improve patient access to accurate product information