Regulatory Affairs, Labeling

🕒 August 7

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 53%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Perform regulatory impact assessments for change controls raised in TrackWise for medicinal products registered via CP, MRP, DCP, or NP • Manage product information updates, including creation and updates of the Company Core Data Sheet (CCDS), applying clinical expertise • Prepare and submit variations, notifications, and renewals to Health Authorities • Respond to Health Authority questions on submissions • Coordinate labeling updates, including translations, with team members and client stakeholders • Manage required post-approval activities in Veeva Regulatory Information Management System (RIMS), including artwork updates • Collaborate with cross-functional teams and client stakeholders • Contribute to regulatory and labeling operations from planning through post-approval activities

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field, or equivalent professional experience • 6+ years of experience in regulatory affairs or regulatory labeling • Knowledge of regulatory requirements and Health Authority submission processes for medicinal product labeling • Clinical expertise to support product information and CCDS updates • Knowledge of Veeva RIMS • Comfort working with Veeva RIMS and TrackWise • Experience working in clinical research, healthcare, or a regulated environment • Fluent in English • Strong coordination, communication, organization, planning, and attention-to-detail skills • Patient-focused mindset • Ability to plan variation submissions to meet timelines, quality requirements, and KPIs • Familiarity with xEVMPD preferred

🏖️ Benefits

• Remote work capacity • Flexibility • Growth opportunities • Continuous learning opportunities • Career path exploration and skill expansion • Opportunity to contribute to meaningful clinical research outcomes