Senior Regulatory Affairs Consultant, CMC Drug & Device Expert

February 19

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Parexel

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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

• Provides strategic regulatory guidance to cross-functional project teams for product development. • Recommends and implements global CMC regulatory strategies. • Interacts with regulatory agencies to negotiate agreements. • Coordinates regulatory agency meetings on CMC. • Supports departmental activities related to clinical trial conduct and CMC regulatory submissions. • Acts as an advisor with functional units on Drug-Device Combination and Medical Device regulatory requirements. • Contributes to IND, NDA and MAA and related CMC regulatory submissions and responses to regulatory agency requests. • Works closely with Regulatory Publishing to ensure electronic Common Technical Document compliance. • Assists in development of risk assessment plans and presents for review/approval. • Represent regulatory function in evaluation of new product opportunities.

🎯 Requirements

• Bachelors or Masters degree in a scientific discipline. • PhD or PharmD or equivalent experience strongly preferred. • Regulatory Affairs Certification highly preferred. • Minimum of 6 years of CMC regulatory experience within the pharmaceutical or biotechnology industry. • Knowledge of the regulatory framework for Combination Products/Medical Devices in major markets is essential. • Significant experience with registration of Combination Products/Medical Devices. • Proven track record of contributing to design and execution of creative development strategies and programs for drugs and/or biologics/vaccines. • Comprehensive experience in the drug development process in the US. • Comprehensive experience in the drug development process internationally (particularly in Japan, Europe, and Canada) is preferred. • Experience in the post marketing area and with related requirements. • Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.