Senior Regulatory Affairs Associate – Labeling Strategy

🕒 June 30

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 55%

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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

• Develop, maintain, and update global labeling documents including CCDS, USPI, and regional labels for US, EU, Switzerland, Canada, Australia, and other markets • Manage post-approval labeling activities including artwork updates, safety variations, xEVMPD submissions, and PSURs • Conduct Regulatory Impact Assessments for change controls raised for medicinal products in registered markets • Coordinate artwork approval processes for printed packaging components • Troubleshoot and manage SPL activities and review and approve labeling in document management systems • Monitor and manage artwork change requests and oversee artwork creation and translation processes • Maintain Artwork Trackers and related systems • Research and prepare comparator labeling documents for global alignment and competitive analysis • Author labeling components of Annual Reports • Liaise with internal and external stakeholders to implement labeling changes across regions

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field, or equivalent professional experience • 7-8 years of experience in pharmaceutical regulatory affairs, with demonstrated expertise in labeling development and post-approval activities • In-depth knowledge of labeling regulations and guidelines across major markets (US, EU, Switzerland, Canada, Australia) • Hands-on experience with CCDS-related submissions, safety variations, and artwork management • Proficiency in SPL and document management systems • Strong communication, organization, and problem-solving skills with the ability to manage multiple priorities • Experience with regulatory information management systems and labeling tools • Advanced degree (Master's) in Regulatory Affairs or related field (preferred) • Experience with regulatory information management systems such as Veeva, TVT, or Docubridge (preferred) • Knowledge of advertising and promotion materials regulations (preferred) • Experience managing labeling across multiple therapeutic areas (preferred)

🏖️ Benefits

• Flexible work arrangements • Growth opportunities • Continuous learning opportunities