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.
