Senior Regulatory Operations Specialist; Remote

At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life®, Nature's Bounty®, Vital Proteins®, Orgain®, Nuun®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.

At Nestlé Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way.

We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.

Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.

The Senior Regulatory Operations Specialist is an experienced individual contributor who plans, coordinates, publishes, delivers, and maintains global regulatory submissions. The role works with Regulatory Affairs, content owners, technology teams, and external providers to deliver accurate, compliant, and timely dossiers across development, registration, and post-approval activities.

The role also maintains reliable regulatory information, documents, and submission records in approved systems. Responsibilities include supporting inspection readiness, performance reporting, process improvement, and the appropriate use of approved AI and automation tools in line with company controls, data protection, and human review requirements.

• Global Submission Planning and Delivery
  • Lead the operational delivery of assigned global regulatory submissions across development, registration, and post-approval lifecycle stages.
  • Develop submission plans, timelines, dependencies, forecasts, and resource needs with Regulatory Leads and cross-functional contributors.
  • Identify risks and critical dependencies, recommend solutions, and elevate issues that may affect quality, compliance, cost, or timing.
  • Represent Regulatory Operations on submission teams and advise on dossier format, 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 coordinate resolution of technical issues.
  • Track health-authority questions, correspondence, commitments, and response timelines.
• Publishing and Dossier Lifecycle Management
  • Perform or oversee document formatting, links, bookmarks, technical quality checks, and eCTD lifecycle activities.
  • Maintain accurate submission sequences, document reuse, lifecycle history, and active dossiers.
  • Stay current on submission standards and data requirements, including eCTD 4.0, and assess their operational impact.
  • Confirm that literature references and other third-party content are cleared and ready for submission, when applicable.
• Regulatory Information Management and Data Stewardship
  • Store, track, reconcile, transfer, and archive submissions, approvals, correspondence, commitments, and related records in approved systems.
  • Maintain accurate and…