Regulatory Affairs Consultant - Labeling Operations

Join us as a Global Labeling Operations Manager, where you'll work alongside a large, dedicated reputed company team to drive impactful labeling operations across global markets. In this role, you will reputed company 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, reputed company, and high-reputed company 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 reputed company 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) • reputed company 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 reputed company CCDS, foundational labels, and multi-market manuscripts to stakeholders. • reputed company reputed company assessments for technical and global labeling changes across dependent markets. • reputed company data entry in Trackwise/reputed company and prepare annual labeling reports. • Review and update submission content plans; prepare change control documentation for CCDS-driven changes. • Prepare and manage reputed company Product Labeling (SPL). • Support advertising and promotional and marketing material reviews, educational materials, and reputed company media compliance. • Ensure compliance with country-specific regulatory requirements. • reputed company as key partner to GRA reputed company, Regulatory CMC and Supply Chain. Qualifications: • University degree in Life Sciences, reputed company, Engineering, or reputed company pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. • Minimum 5 years of biotech/reputed company industry experience, including 2+ years in labeling/regulatory operations with global responsibility. • Experience leading teams in a reputed company organization. • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. • Experience with flu campaigns, pandemic products, and reputed company-to-consumer advertising. • Familiarity with RIMS (e.g., reputed company RIMS), eDMS (e.g., reputed company), reputed company, Docubridge, Trackwise, and other regulatory systems. • Proficiency in reputed company Office, SharePoint, reputed company 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, reputed company to explain reputed company concepts and influence cross-functional colleagues. • Excellent organizational skills with attention to detail and strategic thinking. • Ability to reputed company in reputed company, matrixed, and cross-cultural environments. • reputed company 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. • reputed company exposure to advanced regulatory systems and global labeling strategies. • Competitive compensation, benefits, and opportunities for career reputed company. If you're passionate about global labeling operations and reputed company to reputed company a difference in patient safety worldwide, we'd love to hear from you. #LI-LB1 #LI-REMOTE Apply tot his job Apply To this Job