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As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. Join us as a Global Labeling Operations Senior Regulatory Affairs Associate, 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.
Job Responsibility:
Manager internal global labeling and drug safety activities and coordinate bi-weekly updates
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
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
Requirements:
University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field
advanced degree (MSc, PhD, PharmD) preferred
Fluency in English (verbal and written)
additional languages a plus
Minimum 3 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations
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
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
Nice to have:
Advanced degree (MSc, PhD, PharmD)
additional languages
What we offer:
Competitive compensation, benefits, and opportunities for career growth