Parexel
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.
Senior Regulatory Affairs Consultant – Ad Promo
🕒 May 20
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Parexel
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
• Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams • Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations • Independently review and approve promotional and non-promotional materials • Proactively interpret and apply FDA guidance, identifying risks and opportunities • Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations • Provide strategic input early in the development lifecycle • Partner with Legal and Medical Affairs to ensure balanced, compliant communications • Lead discussions on risk assessment and mitigation strategies • Support and lead regulatory review committees • Stay current with regulatory trends and best practices • Mentor junior team members
🎯 Requirements
• 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry • Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities • Proven ability to act as a strategic advisor and trusted partner to senior stakeholders • Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams • Demonstrated ability to independently review promotional materials and make sound regulatory decisions • Strong experience in interpreting and applying FDA guidance to real-world scenarios • Excellent communication, influence, and stakeholder management skills • Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset
🏖️ Benefits
• Health insurance • Professional development opportunities
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