Senior Regulatory Affairs Consultant - Labeling (European Expertise)

Senior / Consultant, Regulatory Labeling

Incredible, high-impact role with a Global Biopharma sponsor! Are you ready to turn your labeling expertise into strategic impact? We're seeking a sharp, detail-driven Senior / Consultant, Regulatory Labeling to join a dedicated partnership with a leading global biopharmaceutical company. In this high-visibility role, you'll be more than a consultant you'll be a trusted collaborator whose insights help shape regulatory strategy and ensure patients worldwide receive safe, effective therapies with clarity and confidence.

In this role, you'll be the go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs, Technical Operations, Safety, and Commercial. You'll help navigate the complex regulatory landscape, ensure compliance across international markets, and drive continuous improvement in how labeling is developed, tracked, and delivered. As a Senior / Consultant, Regulatory Labeling, you will partner with Label Strategist to :

• Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
• Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
• Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
• Utilize regulatory / product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.

You will also :

Business Development :

Parexel-related Responsibilities :

Skills :

Knowledge and Experience :

Education :

If you thrive in fast-paced, high-stakes environments and love the idea of being a key player in a global regulatory role - apply today!