Global Regulatory Submissions Lead

Nestlé Health Science; Bridgewater (MA); Sur place; USD 87 000 - 123 000; Plein temps

Avantages offerts par ce poste

401k with company match

Healthcare coverage

Bonus eligibility

Résumé du poste

Nestlé Health Science seeks a Senior Regulatory Operations Specialist to plan, publish, and maintain global regulatory submissions across development, registration, and post-approval activities.

You will collaborate with Regulatory Affairs, content owners, technology teams, and external providers to ensure accurate, timely dossiers, support inspection readiness, and maintain data integrity using approved AI and automation tools.

Qualifications

• Bachelor’s degree in life sciences, information management, technology, or related field.
• 6–8 years of pharmaceutical/regulatory experience; strong preference for Regulatory Operations.
• At least 3 years in electronic submission publishing or dossier management.
• Experience with global submissions (US/Europe; other markets preferred).
• Experience coordinating cross-functional submission teams and external providers.

Responsabilités

• Lead global regulatory submissions planning and delivery across development, registration, and post-approval stages.
• Publish, format, and manage eCTD lifecycles and archival processes.
• Maintain regulatory data in information management systems and support inspections/audits.
• Ensure compliance with regulations, procedures, data integrity, and AI/tool usage controls.
• Coordinate with external vendors and manage performance and budgets.
• Develop procedures, templates, and training; drive process improvements.

Connaissances

Submission leadership

Project execution

Risk identification

Data stewardship

Stakeholder management

Clear communication

Multitasking

Continuous improvement

Independent yet collaborative

Formation

Bachelor’s degree in life sciences

Regulatory Affairs Certification (preferred)

Outils

Regulatory information management systems

Description du poste

Nestlé Health Science seeks a Senior Regulatory Operations Specialist to plan, publish, and maintain global regulatory submissions across development, registration, and post-approval activities.

You will collaborate with Regulatory Affairs, content owners, technology teams, and external providers to ensure accurate, timely dossiers, support inspection readiness, and maintain data integrity using approved AI and automation tools.