Senior Regulatory Affairs Consultant – CMC Biologics

🕒 Setembro 14

🇺🇸 Estados Unidos – Remoto (EUA)

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Venture Round em 1990-01

Consulting • Healthcare • Logistics

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• Support regulatory leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products • Determine regulatory and scientific/technical requirements for CMC and GMP-related submissions and regulatory inquiries • Represent CMC regulatory affairs in project team meetings and provide regulatory guidance and perspective to cross-functional teams in conjunction with global regulatory leads • Prepare, coordinate, and review CMC and GMP-related documents for submission to regulatory authorities • Develop CMC regulatory strategies for developmental phase products from early development through marketing applications • Support post-approval changes for marketed products • Interact with manufacturing, quality, and partner organizations to address CMC-related issues and ensure alignment • Develop and maintain relationships with local and global functional units, manufacturing sites, contract manufacturers, and external partner companies • Support preparation for health authority CMC meetings and mock meetings • Assess and develop ideas to optimize CMC regulatory departmental processes and improve efficiencies • Support regulatory strategy and compliance for drug development across investigational, new, and marketed products • Collaborate with manufacturing, quality, and project management teams • Contribute to product development from early stages through post-approval

🎯 Requisitos

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD) • 7+ years of CMC experience in the pharmaceutical industry with a demonstrated history of successful regulatory filing documentation • Comprehensive knowledge of drug development processes, pharmaceutical technology, drug manufacturing processes, and GMP requirements • Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products • Comprehensive experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada • Comprehensive understanding of the global regulatory environment • Strong analytical, problem-solving, organizational, and negotiation skills • Strong collaborative, interpersonal, communication, and presentation skills • Demonstrated ability to work independently, manage multiple projects, and prioritize in a matrixed environment • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook) • Experience working in pharmaceutical development, regulatory affairs, or a highly regulated environment • Comfort working with regulatory information systems, document management platforms, and Microsoft Office applications

🏖️ Benefícios

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Additional benefit offerings in accordance with applicable plans • Some roles may be eligible for additional incentives, bonuses, or other compensation programs