Manager, Regulatory Intelligence

🕒 Outubro 22

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $120.000 - $180.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Zoetis

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1952

🏥 Saúde

🍽️ Alimentos e Bebidas

🏭 Manufatura

Healthcare • Food & Beverage • Manufacturing

A Zoetis é a principal empresa de saúde animal do mundo, comprometida em nutrir o mundo e a humanidade ao avançar nos cuidados com os animais. Com mais de 70 anos de inovação, a Zoetis desenvolve um amplo portfólio e pipeline de medicamentos, vacinas, diagnósticos e tecnologias que abrangem um continuum de cuidados para prever, prevenir, detectar e tratar doenças animais. Operando em mais de 100 países, a empresa apoia agricultores, veterinários e donos de animais de estimação ao redor do mundo. A Zoetis é impulsionada pela ciência e pela paixão compartilhada pelo vínculo humano-animal, com o objetivo de criar um mundo mais sustentável e saudável para todos.

Descrição

• Own and lead assigned global regulatory surveillance workstreams, with a focus on the USA and Canada • Monitor, interpret, and communicate evolving regulatory requirements across compendial changes, chemical requirements, packaging, diagnostics, medical devices, and GMP/Environmental inspectional activities • Coordinate cross-functional impact assessments with EHS, VMRD, Quality, Global Manufacturing, Public Affairs, and Legal • Ensure compliance plans are documented and actions are tracked to closure • Develop and distribute regulatory intelligence newsletters, regulatory watch notifications, and ad hoc query responses • Review and quality-check RI communications produced by team members • Coordinate company responses to draft guidance, standards, and consultations • Manage SME engagement, consolidate inputs, and ensure submissions reflect a clear, defensible company position • Represent the company in industry associations and regulatory forums; contribute to working groups and industry-level regulatory positions • Administer Producer Responsibility Organization obligations and Extended Producer Responsibility reporting, including data submission to state and/or national programs • Serve periodically as a subject matter expert on new and emerging regulations or requirements • Coordinate external consultant activities, including scope definition, budget review and approval, and liaison • Serve as primary contact for assigned internal stakeholder groups for regulatory intelligence inquiries • Interpret compliance trends, assess emerging risks, and prepare action plans and briefings for Governance forums • Contribute to the design, documentation, and sustainability of RI processes and SOPs • Champion AI-enabled regulatory intelligence platforms and support selection, piloting, implementation, and team training

🎯 Requisitos

• Bachelor’s degree in a scientific discipline (e.g., life sciences, pharmacy, regulatory affairs, or related field) • Minimum 5 years of experience in Regulatory Affairs or related field • Demonstrated track record of independently managing regulatory deliverables and leading cross-functional workstreams or acting as Subject Matter Expert within a cross-functional team • Experience with regulatory intelligence systems or tools required at this level • Previous interactions with FDA, USDA, or other US authorities strongly preferred • Experience in a Regulatory Intelligence function preferred • General knowledge of (bio) pharmaceutical research and development, authorization and post-marketing compliance of medicinal products • Good understanding of CMC preferred • Experience as an active participant or representative in industry associations, with demonstrated contribution to working groups or policy discussions • Working knowledge of animal health product laws, regulations, and the regulatory policy-making process • Understanding of chemical substances laws and regulations • Familiarity with sustainability and packaging regulations, including US State EPR reporting frameworks and PRO data submission requirements • Experience managing a portfolio of regulatory liaison activities directly with Global Health Authorities • Hands-on experience with AI software and GenAI technology applied to regulatory intelligence workflows • All applicants must possess or obtain authorization to work in the US for Zoetis

🏖️ Benefícios

• Short-term incentive compensation • Long-term incentives • Healthcare and insurance benefits beginning on day one • 401K plan with a match and profit-sharing contribution from Zoetis • 4 weeks of vacation

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