Regulatory Affairs Consultant - Labeling Operations

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 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.

•             Com