Regulatory Affairs Consultant - Labeling Operations
Join us as a Global Labeling Operations Manager, where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global markets. In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely, and high-quality labeling updates. This is a unique opportunity to work on diverse programs, including pandemic products and flu campaigns, while contributing to the governance, compliance, and strategy of global labeling. Key Responsibilities: • Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership. • Coordinate readability testing (planning, team review, and communications) • Oversee translations for foundational markets (EU, CH, DE). • Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL). • Upload approved labels to internal systems (Documentum, Weblabel, intranet). • Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders. • Lead impact assessments for technical and global labeling changes across dependent markets. • Perform data entry in Trackwise/Veeva and prepare annual labeling reports. • Review and update submission content plans; prepare change control documentation for CCDS-driven changes. • Prepare and manage Structured Product Labeling (SPL). • Support advertising and promotional and marketing material reviews, educational materials, and social media compliance. • Ensure compliance with country-specific regulatory requirements. • Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: • University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. • Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility. • Experience leading teams in a matrix organization. • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. • Experience with flu campaigns, pandemic products, and direct-to-consumer advertising. • Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems. • Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS. Competencies: • Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing. • Strong problem-solving skills with the ability to analyze risk and recommend solutions. • Effective communicator, able to explain complex concepts and influence cross-functional colleagues. • Excellent organizational skills with attention to detail and strategic thinking. • Ability to thrive in complex, matrixed, and cross-cultural environments. • Fluency in English (verbal and written); additional languages a plus. Why Join Us: • Work on impactful global programs that directly support patient safety and regulatory compliance. • Collaborate with a diverse, international team across multiple therapeutic areas. • Gain exposure to advanced regulatory systems and global labeling strategies. • Competitive compensation, benefits, and opportunities for career growth. If you're passionate about global labeling operations and ready to make a difference in patient safety worldwide, we'd love to hear from you. #LI-LB1 #LI-REMOTE Apply tot his job