Senior Regulatory Affairs Associate - Biologics

September 15

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Parexel

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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

• Senior Regulatory Affairs Associate role focused on drug product lifecycle management. • Contribute to the preparation and delivery of regulatory submissions. • Liaise closely with cross-functional team members with aligned product responsibilities. • Execute and maintain submission delivery plans, proactively provide status updates to stakeholders. • Prepare, review and submit safety variations to Health Authorities and perform post-Approval CMC updates.

Requirements

• 4-8 years of relevant experience in handling pre and post approval life cycle management of drug products. • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures. • Experience in handling CMC-related health authority queries. • Knowledge of EU/US regulatory procedures including post-approval requirements. • Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products. • Regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements. • Strong communication skills and ability to guide and mentor team members. • Ability to work independently.