Regulatory Submissions Coordinator, Biological Products

🕒 2 days ago

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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

• Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities • Assist in organizing submission team meetings • Coordinate, request, and track documentation from Subject Matter Experts (SMEs) • Support the preparation and maintenance of the Submission Content Plan (SCP) • Ensure timely dispatch of non-eCTD submission packages • Provide hands-on operational support for labeling activities • Prepare annotated labeling documents for regulatory review • Initiate and coordinate mock-up requests in the Artwork Management System • Track print releases as required • Support change control activities related to local labeling updates • Ensure appropriate archiving of labeling documentation • Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems • Upload Module 1 and non-eCTD submission documents to DocNet • Update regulatory systems with Health Authority interactions • Provide regular status updates to the Regional Submission Coordinator (Lead) • Support tracking of submission milestones, deliverables, and dependencies • Collaborate effectively with cross-functional teams • Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline • Associate: 1–3 years of experience, Sr Associate +3 years in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role • Experience with Biological Products (Mandatory) • Experience with regulatory submission processes and lifecycle management activities • Experience with Veeva RIM and document management tools • Effective written and verbal communication skills in English and Spanish (mandatory) • Strong organizational skills with attention to detail and quality • Ability to manage multiple tasks and timelines in a matrix environment

🏖️ Benefits

• Health insurance • 401(k) • Flexible work arrangements • Paid time off • Professional development