Senior Regulatory Affairs Consultant, CMC – Post-Approval Vaccines

🕒 Outubro 28

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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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

• Provide strategic direction and oversight for CMC aspects of late-stage and marketed products • Develop and oversee CMC strategies for product development, registration, and lifecycle management • Lead complex regulatory submissions, including INDs, IMPDs, BLAs, MAAs, post-approval variations and supplements, and responses to health authority questions • Author and review high-level regulatory submissions and ensure compliance with health authority guidelines and regulations • Lead submission preparation meetings with coordinated cross-functional input • Lead regulatory CMC discussions and interactions with health authorities • Represent the company in high-level meetings with regulatory agencies and maintain relationships with regulatory stakeholders • Develop strategies for complex regulatory questions and manage sensitive regulatory correspondence • Oversee regulatory assessments of manufacturing changes and establish data requirements for related submissions • Represent Regulatory CMC at project team meetings and governance committees • Collaborate with R&D, Manufacturing, Quality Assurance, Clinical Development, external partners, and regulatory authorities • Provide senior management updates on project status, risks, and milestones • Mentor and develop team members in Regulatory CMC practices and strategic thinking • Monitor evolving CMC regulations and industry best practices and develop innovative regulatory strategies

🎯 Requisitos

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field • Minimum of 10+ years of experience in Regulatory Affairs, with a strong focus on CMC for late-stage and marketed products • Extensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations • Deep understanding of pharmaceutical development, manufacturing processes, and quality systems • Proven track record of successful regulatory submissions and positive health authority interactions • Strong analytical, communication, organization, and problem-solving skills • Excellent project management skills and ability to influence and lead at senior levels • Experience working in a regulated pharmaceutical environment, focused on CMC for late-stage and marketed products • Ability to collaborate across senior leadership teams, influence cross-functional stakeholders, and communicate clearly at every level • Comfort working with global regulatory submission processes, health authority expectations, and quality systems

🏖️ 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 • Some roles may also be eligible for additional incentives, bonuses, or other compensation programs

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