Senior Regulatory Operations Specialist

Job not on LinkedIn

🔥 6 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $86.6k - $123.3k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Nestle

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🍽️ Food & Beverage

🏭 Manufacturing

📦 Logistics

Food & Beverage • Manufacturing • Logistics

Nestle is a Swiss multinational food and beverage company that produces and markets a wide range of packaged foods and beverages, including coffee, bottled water, dairy products, infant nutrition, confectionery, frozen foods, and pet care brands. The company sells its products globally through retail and foodservice channels, operates extensive manufacturing and supply-chain operations, and focuses on nutrition, health, and wellness initiatives.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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