Senior Regulatory Operations Lead - Remote

Nestlé S.A.

Bridgewater Township (NJ)

Remote

USD 87,000 - 123,000

Full time

4 days ago
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Benefits offered by this job

401k with company match
Healthcare coverage
Performance‑based incentives

Job summary

Nestlé Health Science is seeking a Senior Regulatory Operations Specialist (Remote) to lead global submissions and ensure timely, compliant dossiers across development to post‑approval. You will coordinate with Regulatory Affairs, content owners, and external providers, maintaining records and supporting inspection readiness.

Responsibilities span planning, publishing, data stewardship, and governance, with emphasis on AI/automation use per company controls.

Qualifications

  • Bachelor’s degree in life sciences, information management, technology, or a related field or equivalent experience.
  • 6–8 years in pharmaceutical/biotech regulatory operations preferred.
  • 3+ years in electronic submission publishing and dossier management.

Responsibilities

  • Lead global regulatory submissions across development, registration, and post‑approval lifecycle stages.
  • Publish and manage dossiers with accuracy, ensuring compliance with eCTD 4.0 standards.
  • Maintain regulatory data in approved systems and support inspections and audits.

Skills

Submission leadership
Regulatory submissions
Project management
Cross-functional collaboration
Data governance
Communication

Education

Bachelor’s degree in life sciences or related field

Job description

Nestlé Health Science is seeking a Senior Regulatory Operations Specialist (Remote) to lead global submissions and ensure timely, compliant dossiers across development to post‑approval. You will coordinate with Regulatory Affairs, content owners, and external providers, maintaining records and supporting inspection readiness.

Responsibilities span planning, publishing, data stewardship, and governance, with emphasis on AI/automation use per company controls.

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