Regulatory Affairs Consultant – Labelling Strategy

🕒 March 21

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

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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

• Act as a labeling strategist within Global Regulatory Affairs (GRA) • Drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio • Ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area • Manage the exception process between the CCDS and the USPI and EU SmPC • Collaborate with relevant Subject Matter Experts and stakeholders • Ensure consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products • Maintain compliance by leading the assessment and Global Labeling Committee review of proposed exceptions • Represent Global Labeling on respective product Global Regulatory Affairs Strategy Teams

🎯 Requirements

• University degree in Life Sciences or related Pharmaceutical field • Minimum of 7 years of biotech/pharmaceutical industry experience, including 4 years of labeling/regulatory experience combined with other global responsibility • Knowledge and understanding of principles of regulatory relevant to drug development, global labeling, and post-marketing requirements • Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions • Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact • Attention to detail, coupled with the ability to think strategically • Fluency in English (verbal and written)

🏖️ Benefits

• Health insurance • Professional development opportunities • Flexible working arrangements