Senior Regulatory Operations Specialist (Remote)

About the role

Nestlé Health Science is seeking a Senior Regulatory Operations Specialist to plan, coordinate, publish and maintain global regulatory submissions across development, registration and post‑approval stages. The role works closely with Regulatory Affairs, content owners, technology teams and external providers to ensure accurate, compliant and timely dossiers.

Key responsibilities

• Lead operational delivery of global regulatory submissions, develop plans, timelines and resource forecasts.
• Coordinate submission preparation, publishing, quality review, validation, delivery and archiving.
• Maintain submission sequences, document reuse and lifecycle history, ensuring compliance with eCTD 4.0 standards.
• Store, track and reconcile submissions, approvals and correspondence in approved systems, supporting inspection readiness.
• Manage external service providers, monitor performance, budgets and invoices.

Required profile

• Bachelor’s degree in life sciences, information management, technology or related field, or equivalent experience.
• 6‑8 years of pharmaceutical/biotechnology regulatory experience, including at least 3 years in electronic submission publishing.
• Experience supporting global submissions to US, EU and other markets.

Required skills

• eCTD 4.0 submission standards and electronic publishing tools.
• AI and automation tools for regulatory operations with appropriate controls.
• Regulatory information and document management systems for data stewardship.