Regulatory Affairs Consultant - Labeling Operations

Join us as a Global Labeling Operations Manager , where youu2019ll 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: u2022 Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership. u2022 Coordinate readability testing (planning, team review, and communications) u2022 Oversee translations for foundational markets (EU, CH, DE). u2022 Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL). u2022 Upload approved labels to internal systems (Documentum, Weblabel, intranet). u2022 Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders. u2022 Lead impact assessments for technical and global labeling changes across dependent markets. u2022 Perform data entry in Trackwise/Veeva and prepare annual labeling reports. u2022 Review and update submission content plans; prepare change control documentation for CCDS-driven changes. u2022 Prepare and manage Structured Product Labeling (SPL). u2022 Support advertising and promotional and marketing material reviews, educational materials, and social media compliance. u2022 Ensure compliance with country-specific regulatory requirements. u2022 Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: u2022 University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. u2022 Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility. u2022 Experience leading teams in a matrix organization. u2022 Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. u2022 Experience with flu campaigns, pandemic products, and direct-to-consumer advertising. u2022 Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems. u2022 Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS. Competencies: u2022 Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing. u2022 Strong problem-solving skills with the ability to analyze risk and recommend solutions. u2022 Effective communicator, able to explain complex concepts and influence cross-functional colleagues. u2022 Excellent organizational skills with attention to detail and strategic thinking. u2022 Ability to thrive in complex, matrixed, and cross-cultural environments. u2022 Fluency in English (verbal and written); additional languages a plus. Why Join Us: u2022 Work on impactful global programs that directly support patient safety and regulatory compliance. u2022 Collaborate with a diverse, international team across multiple therapeutic areas. u2022 Gain exposure to advanced regulatory systems and global labeling strategies. u2022 Competitive compensation, benefits, and opportunities for career growth. If youu2019re passionate about global labeling operations and ready to make a difference in patient safety worldwide, weu2019d love to hear from you. #LI-LB1 #LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Created: 2025-12-15