Regulatory Affairs Consultant

🕒 March 18

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

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.

📋 Description

• Handle life cycle management (LCM) of approved/marketed drug products in various markets • Lead and contribute to regulatory submissions from a global and/or regional perspective • Author and review regulatory submissions for various medicinal products and therapeutic areas • Collaborate with various teams and stakeholders to ensure compliance and efficient submissions

🎯 Requirements

• Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products • Good understanding of regulatory framework including regional trends for various types of applications and procedures • Lead and/or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions • Working knowledge of US, EU, Japan, Canada, Switzerland, Australia regulatory procedures • Knowledge of ROW markets regulatory legislations would be an added advantage • Experience in handling CMC related health authority queries and author responses to HA requests • Preparation/Review of Regulatory gap analysis and strategy documents for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications • Authoring and review of CMC component of Marketing Authorization Applications & Variations • Evaluation of change controls and deviations and identification of required documentation and strategy • Coordination with internal and external stakeholders for documentation required for various submissions • Develop up-to-date knowledge about regulatory guidelines updates and apply regulatory requirements • Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault

🏖️ Benefits

• Health insurance • Flexible working arrangements • Professional development opportunities