Senior Regulatory Affairs Associate

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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

• Contribute to the preparation, including relevant authoring, and delivery of simple and increasingly complex regulatory maintenance submissions from global and/or regional perspectives • Author and review CMC components of Marketing Authorization Applications and Variations for medicinal products filed in the EU • Prepare documentation for Super Grouping, Grouping, and Work-sharing variation procedures • Review DMFs, batch records, specifications, and stability data for regulatory compliance • Author CMC components of annual reports, renewals, GMP submissions, and site registrations • Provide regulatory impact assessments for change controls and identify required documentation for EU/US and other-market submissions • Liaise closely with cross-functional members with aligned product responsibilities • Execute and maintain submission delivery plans and submission content plans • Proactively provide status updates to designated stakeholders • Prepare, review, and submit safety variations to Health Authorities • Perform post-approval CMC-related updates • Author label content for the EU, Canada, Australia/New Zealand, and US based on CCDS, PRAC, and CMDH recommendations • Guide and mentor team members

🎯 Requirements

• Relevant experience handling life cycle management of approved drug products, including small molecules and biologicals such as vaccines and monoclonal antibodies, across various markets • Good understanding of regulatory frameworks and regional trends for various application types and procedures • Working knowledge of EU/US regulatory procedures, including post-approval requirements • Experience handling CMC-related health authority queries and authoring responses • Knowledge of global pharmaceutical legislation and ICH regulatory CMC guidance • Experience authoring and reviewing CMC components of Marketing Authorization Applications and Variations for oral and parenteral medicinal products • Experience with EU DCP, MRP, and National Procedures • Experience preparing Super Grouping, Grouping, and Work-sharing variation documentation • Experience reviewing DMFs, batch records, specifications, and stability data for regulatory compliance • Experience authoring CMC components of annual reports, renewals, GMP submissions, and site registrations • Experience providing regulatory impact assessments for change controls and identifying documentation requirements • Experience with Regulatory Information Management Systems such as Veeva Vault • Strong communication skills and ability to guide and mentor team members • Ability to work independently • Familiarity with EU Guidelines for QRD and Excipients