Senior Regulatory Affairs Associate

🕒 March 24

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 45%

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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

• Submitting labelling / safety variations in EU countries including UK and Ireland • Preparation and review of M1 documents – Cover letter, eAF , Mock-ups, Clinical Overview, Literature References • Handled MRP and National procedures in EU • Updating the labelling impacted documents - SmPC, PIL and/or Label Artwork update coordination • Veeva experience with tracking submissions, updating status, creating HAQ’s

🎯 Requirements

• Submission of labelling / safety variations in EU countries including UK and Ireland • Preparation and review of M1 documents – Cover letter, eAF , Mock-ups, Clinical Overview, Literature References • Handled MRP and National procedures in EU • Updating the labelling impacted documents - SmPC, PIL and/or Label Artwork update coordination • Veeva experience with tracking submissions, updating status, creating HAQ’s

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