Senior Regulatory Operations Specialist

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🕒 Setembro 9

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $86.575 - $123.298 / ano

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 23%

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Nestle

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

🍽️ Alimentos e Bebidas

🏭 Manufatura

📦 Logística

Food & Beverage • Manufacturing • Logistics

A Nestlé é uma multinacional suíça de alimentos e bebidas que produz e comercializa uma ampla gama de alimentos e bebidas embalados, incluindo café, água engarrafada, produtos lácteos, nutrição infantil, confeitaria, alimentos congelados e marcas de cuidados com animais de estimação. A empresa vende seus produtos globalmente através de canais de varejo e serviços de alimentação, opera extensas operações de fabricação e cadeia de suprimentos, e foca em iniciativas de nutrição, saúde e bem-estar.

Descrição

• Lead operational delivery of assigned global regulatory submissions across development, registration, and post-approval lifecycle stages • Develop submission plans, timelines, dependencies, forecasts, and resource needs • Identify risks and dependencies, recommend solutions, and escalate issues affecting quality, compliance, cost, or timing • Represent Regulatory Operations on submission teams and advise on dossier formats, technical requirements, content readiness, schedules, and deliverables • Coordinate submission preparation, publishing, quality review, validation, delivery, and archiving • Monitor health-authority receipts and validation results and resolve technical issues • Track health-authority questions, correspondence, commitments, and response timelines • Perform or oversee document formatting, links, bookmarks, technical quality checks, and eCTD lifecycle activities • Maintain submission sequences, document reuse, lifecycle history, active dossiers, regulatory data, product records, and submission status • Support inspections, audits, due diligence, system validation, access controls, audit trails, change control, investigations, corrective actions, and process improvements • Coordinate external service providers and support vendor onboarding, governance, budgets, invoices, service expectations, and performance monitoring • Report Regulatory Operations metrics and identify trends, risks, capacity constraints, and improvement opportunities • Monitor regulatory requirements, data standards, tools, portals, and guidance; develop procedures, templates, training materials, and process guidance • Lead or contribute to system, submission-process, department improvement, integration, migration, merger, acquisition, and divestiture initiatives • Use approved AI, analytics, and automation tools responsibly while protecting regulated information and ensuring human review, accuracy, compliance, and recordkeeping • Provide coaching, practical guidance, and knowledge sharing to colleagues, content authors, and business partners

🎯 Requisitos

• Bachelor’s degree in life sciences, information management, technology, or a related field, or an equivalent combination of education and relevant experience • At least 6 to 8 years of pharmaceutical, biotechnology, or related life sciences regulatory experience, including substantial Regulatory Operations experience is strongly preferred • At least 3 years of direct experience in electronic submission publishing, technical dossier management, or closely related submission-delivery activities • Experience supporting global submissions, including the United States and Europe • Experience with development, marketing-application, and lifecycle submission types, including INDs, CTAs, NDAs, BLAs, MAAs, NDSs, variations, supplements, amendments, annual reports, renewals, and related responses • Experience with RIM, electronic document management, submission publishing, validation, archiving, and health-authority submission systems • Experience coordinating cross-functional submission teams and external service providers in a regulated environment • Experience working with validated or otherwise controlled systems and processes • Regulatory Affairs Certification is preferred but not required • Knowledge of eCTD 4.0, submission standards, data requirements, regulations, guidance, data integrity standards, and electronic record requirements • Ability to manage multiple priorities, adapt to ambiguity, meet demanding timelines, and work independently and collaboratively • This position is not eligible for Visa Sponsorship

🏖️ Benefícios

• Performance-based incentives/bonus eligibility • 401(k) with company match • Healthcare coverage • Competitive total rewards package • Professional growth and dynamic career paths • Robust development opportunities • Opportunities to learn from talented colleagues around the globe • Benefits supporting physical, financial, and emotional wellbeing • Reasonable accommodations during the recruitment process

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