Senior Regulatory Affairs Consultant – Labeling, European Expertise

November 13

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• 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. • Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines. • Act as operational expert for Global Labeling tracking in RIMs, SPL generation, ensure development and maintenance of templates, collaboration features and system upgrades.

🎯 Requirements

• Bachelor’s Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. • Strong attention to detail • Solid understanding and interpretation of EU/US labeling regulatory requirements • Solid understanding of requirements for tracking of labeling updates • Solid understanding of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice • Ability to recognize and escalate issues

🏖️ Benefits

• Health insurance • Professional development opportunities • Flexible working arrangements • Paid time off