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Senior Regulatory Affairs Manager - Submissions & Compliance

Job in Waunakee, Dane County, Wisconsin, 53597, USA
Listing for: Scientific Protein Laboratories LLC
Full Time position Listed on 2026-11-04
Job specializations:
  • Pharmaceutical
    Healthcare Compliance, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 120000 - 160000 USD Yearly USD 120000.00 160000.00 YEAR

Job Description & How to Apply Below

Scientific Protein Laboratories (SPL) in Waunakee, WI, is seeking a Sr Regulatory Affairs Manager to lead regulatory submissions, develop regulatory strategies, and coordinate with cross-functional teams to ensure compliance across FDA, EMA, and ICH guidelines.

The role emphasizes preparing DMFs, INDs, NDAs, and other regulatory filings, maintaining lifecycle management, and providing strategic regulatory expertise for global product approvals and post-approval changes.

The following opportunity is for a Senior Regulatory Affairs Manager
- Submissions & Compliance with Scientific Protein Laboratories LLC.

This posting is for the Senior Regulatory Affairs Manager
- Submissions & Compliance role at Scientific Protein Laboratories LLC, based in Waunakee, WI, United States.

We are looking to fill the Senior Regulatory Affairs Manager
- Submissions & Compliance position at Scientific Protein Laboratories LLC in Waunakee, WI, United States.

Position Requirements

10+ Years work experience
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