Regulatory Submissions Associate – Biological Products

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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 in accordance with submission strategies defined by the RRL and coordinated by the Regional Submission Coordinator (Lead). • Assist in organizing submission team meetings (e.g., Kick-off Meetings) and follow up on agreed actions. • Coordinate, request, and track documentation from Subject Matter Experts (SMEs) to support submission readiness and timelines. • Support the preparation and maintenance of the Submission Content Plan (SCP) under the guidance of the RSC Lead. • Ensure timely dispatch of non-eCTD submission packages to LRRs and RPRs and track dispatched documentation per country. • Provide hands-on operational support for labeling activities, performing assigned tasks under the guidance of the RSC Lead. • Prepare annotated labeling documents for regulatory review in collaboration with RRLs, LRRs, and RPRs. • 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 and that approved labeling is accurately and timely stored in DocNet. • Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., Veeva RIMS, Apollo). • Upload Module 1 and non-eCTD submission documents to DocNet and ensure completeness and traceability. • Update regulatory systems with Health Authority interactions, including uploading questions received from Health Authorities in the appropriate records. • Support data quality and consistency across systems and documentation repositories. • Provide regular status updates to the Regional Submission Coordinator (Lead) on assigned activities, timelines, and potential issues. • Support tracking of submission milestones, deliverables, and dependencies. • Escalate operational issues or delays to the RSC Lead with appropriate context and proposed mitigation actions. • Collaborate effectively with cross-functional teams including CMC, labeling, quality, and regulatory stakeholders. • Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements. • Support inspection readiness by ensuring accurate, complete, and well-organized submission and labeling documentation.

🎯 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) • Good understanding of regulatory submission processes and lifecycle management activities • Experience with Veeva RIM and document management tools • Strong organizational skills with attention to detail and quality • Ability to manage multiple tasks and timelines in a matrix environment • Effective written and verbal communication skills in English and Spanish (mandatory).

🏖️ Benefits

• Health insurance • Professional development opportunities • Paid time off • Flexible working hours