Regulatory Affairs Consultant - Labeling Operations

Parexel•Southport, NC

12d

About The Position

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.

Requirements

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.
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.

Nice To Haves

advanced degree (MSc, PhD, PharmD) preferred.
Fluency in English (verbal and written); additional languages a plus.

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.