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$132k

Per Year

Position range in Kansas City, MO-KS Metropolitan Statistical Area $61k

• $141k Per Year Senior Manager, CMC Regulatory Affairs (Biologics)
  Travere Therapeutics
  

Occupation:

General and Operations Managers

Location:

Kansas City, MO

• 64118
  

Job Type:

Full Time (30 Hours or More)

Posted:

06/27/2026

Positions available: 1

Source:

FileImport

• Travere Therapeutics
  

Web Site:

travere.wd1.myworkdayjobs.com

Expires:

10/31/2026

Job #:

R-100881MO

Job Requirements and Properties

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Full Time Schedule

Full Time

Job Description

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Department:

107000 Regulatory

Location:

San Diego, USA

• RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.

Our work is rewarding

• both professionally and personally
• because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission
• to identify, develop and deliver life-changing therapies to people living with rare disease.

We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:

The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for biologic products, with a strong focus on late-stage development, Phase 3 programs, and rare disease therapeutics. The Senior Manager serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Technical Operations, Process Development, Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with global regulatory requirements and business objectives. This position requires extensive experience supporting biologics development programs and a strong technical understanding of biologic drug substance and drug product manufacturing, analytical characterization, process development, comparability, and control strategies. The individual will be responsible for driving CMC regulatory submissions, managing Health Authority interactions related to CMC topics, assessing regulatory risks, and supporting successful product approvals and post-approval activities worldwide.

Responsibilities:

CMC Regulatory Strategy, Submissions & Dossier Development

Develop and implement global CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of biologic products. Serve as the CMC Regulatory lead on cross-functional program teams, providing strategic regulatory guidance throughout product development. Assess regulatory risks, develop mitigation strategies, and provide regulatory recommendations to support program goals and business priorities. Contribute to regulatory strategy development for expedited development programs, orphan drug products, and rare disease indications. Lead preparation, review, and submission of CMC documentation for global regulatory filings, including INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, and annual reports. Author and review Module 2 and Module 3 content and ensure consistency across submission components. Coordinate cross-functional contributions to CMC regulatory submissions and ensure compliance with global regulatory requirements and submission standards. Support preparation for major registration milestones, including first marketing applications ...For full information see follow application link.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer