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Regulatory Affairs Consultant - Labeling Operations
Primary Location: United States, Remote Job ID R0000037457 Category Regulatory Affairs Date Posted 12/11/2025Overview
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.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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