Regulatory Affairs Consultant - Labeling Operations

divh2Global Labeling Operations Manager/h2pJoin us as a Global Labeling Operations Manager, where youll 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./ppKey Responsibilities:/pulliManage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership./liliCoordinate readability testing (planning, team review, and communications)/liliOversee translations for foundational markets (EU, CH, DE)./liliCoordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL)./liliUpload approved labels to internal systems (Documentum, Weblabel, intranet)./liliManage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders./liliLead impact assessments for technical and global labeling changes across dependent markets./liliPerform data entry in Trackwise/Veeva and prepare annual labeling reports./liliReview and update submission content plans; prepare change control documentation for CCDS-driven changes./liliPrepare and manage Structured Product Labeling (SPL)./liliSupport advertising and promotional and marketing material reviews, educational materials, and social media compliance./liliEnsure compliance with country-specific regulatory requirements./liliAct as key partner to GRA Regions, Regulatory CMC and Supply Chain./li/ulpQualifications:/pulliUniversity degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred./liliMinimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility./liliExperience leading teams in a matrix organization./liliStrong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management./liliExperience with flu campaigns, pandemic products, and direct-to-consumer advertising./liliFamiliarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems./liliProficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS./li/ulpCompetencies:/pulliDeep understanding of regulatory requirements for drug development, global labeling, and post-marketing./liliStrong problem-solving skills with the ability to analyze risk and recommend solutions./liliEffective communicator, able to explain complex concepts and influence cross-functional colleagues./liliExcellent organizational skills with attention to detail and strategic thinking./liliAbility to thrive in complex, matrixed, and cross-cultural environments./liliFluency in English (verbal and written); additional languages a plus./li/ulpWhy Join Us:/pulliWork on impactful global programs that directly support patient safety and regulatory compliance./liliCollaborate with a diverse, international team across multiple therapeutic areas./liliGain exposure to advanced regulatory systems and global labeling strategies./liliCompetitive compensation, benefits, and opportunities for career growth./li/ulpIf youre passionate about global labeling operations and ready to make a difference in patient safety worldwide, wed love to hear from you./p/div