Labeling - Regulatory Affairs Associate/Sr Associate

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.

Key Responsibilities:

• 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.

Qualifications:

• 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.

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.

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.