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Senior Global CMC Regulatory Strategy Lead

Job in Florham Park, Morris County, New Jersey, 07932, USA
Listing for: Shionogi Inc. (U.S.)
Full Time position
Listed on 2026-10-15
Job specializations:
  • Management
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 140000 - 200000 USD Yearly USD 140000.00 200000.00 YEAR
Job Description & How to Apply Below

Shionogi Inc. (U.S.) is seeking a Senior Manager/Associate Director, Regulatory Affairs CMC to define and execute global CMC regulatory strategies for investigational and/or marketed assets.

The role partners with technical, quality, supply and program teams to deliver submission-ready CMC content with a risk-based approach. You will lead cross‑functional teams, manage timelines, and provide regulatory guidance for submissions, ensuring data integrity and health authority alignment.

This role, Senior Global CMC Regulatory Strategy Lead at Shionogi Inc. (U.S.), could be your next opportunity.

The advertised compensation is 140..

We aim to respond to suitable candidates as soon as possible.

Full responsibilities and requirements are described in the listing above.

Learn more about the Senior Global CMC Regulatory Strategy Lead role in the description above.

We appreciate your interest in this position.

Position Requirements
10+ Years work experience
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