Regulatory Affairs Consultant, Biologics

March 26

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Parexel

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.

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective. • Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.

🎯 Requirements

• 7-9 yrs of experience of authoring, compiling and submission of country-specific submission files (MAA, and post-approval changes) of Biologic products in various markets - Regulated (EU/US/Canada) and Emerging Markets. • Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures. • Working experience in Regulatory Information Management Systems like Veeva Vault. • Strong communications and collaboration skills. • Ability to work independently.

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