Remote Senior Regulatory Submissions Lead

Nestlé USA; Bridgewater Township (NJ); À distance; USD 87 000 - 123 000; Plein temps

Avantages offerts par ce poste

401k with company match

Healthcare coverage

Résumé du poste

Nestlé Health Science seeks a Senior Regulatory Operations Specialist to plan, publish, and maintain global regulatory submissions. The role partners with Regulatory Affairs and external providers to deliver accurate dossiers across development, registration, and post-approval activities.

You will maintain reliable regulatory information, support inspections, and drive process improvements while applying approved AI and automation tools within company controls and data protection requirements.

Qualifications

• Bachelor’s degree in life sciences or related field or equivalent experience.
• 6–8 years of pharmaceutical regulatory experience preferred.
• 3+ years in electronic submission publishing and dossier management.
• Experience with global submissions (US/Europe) preferred.
• Experience coordinating cross-functional teams in regulated environments.

Responsabilités

• Lead the operational delivery of 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 escalate 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.

Connaissances

Submission leadership

Project management

Critical thinking

Risk identification

Data stewardship

Stakeholder management

Clear communication

Matrix teamwork

Formation

Bachelor’s degree in life sciences, information management, technology, or a related field

Description du poste

Nestlé Health Science seeks a Senior Regulatory Operations Specialist to plan, publish, and maintain global regulatory submissions. The role partners with Regulatory Affairs and external providers to deliver accurate dossiers across development, registration, and post-approval activities.

You will maintain reliable regulatory information, support inspections, and drive process improvements while applying approved AI and automation tools within company controls and data protection requirements.