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Global CMC Regulatory Lead: Submissions & Strategy

Job in Duluth, St. Louis County, Minnesota, 55806, USA
Listing for: Pace® Analytical Services
Full Time position
Listed on 2026-09-30
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 110000 - 124000 USD Yearly USD 110000.00 124000.00 YEAR
Job Description & How to Apply Below

Pace® Analytical Services is seeking a senior regulatory affairs professional in Minnesota to lead CMC submissions and global regulatory strategies. The role involves authoring CMC sections, drafting submissions, and coordinating responses with FDA, EMA, and PMDA to ensure compliance across markets.

The ideal candidate has 10+ years in CMC/regulatory affairs, with strong technical writing, attention to detail, and proficiency in regulatory document management systems.

We are currently recruiting a Global CMC Regulatory Lead:
Submissions & Strategy for our team in MN, United States.

This is a great role to take on the Global CMC Regulatory Lead:
Submissions & Strategy role at Pace® Analytical Services.

As a Global CMC Regulatory Lead:
Submissions & Strategy, you will play an important part at Pace® Analytical Services in MN, United States.

We invite applications for the Global CMC Regulatory Lead:
Submissions & Strategy position located in MN, United States.

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