New · posted Oct 15
Travere Therapeutics · Biotechnology
Senior Manager, CMC Regulatory Affairs (Biologics)
- San Diego, CA
- Hybrid
- Full-time
- Manager
Open until filled
The role
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.
Department:
107000 Regulatory
Location:
San Diego, USA- Remote
Be 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.
What you need
Education/Experience Requirements
- Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required. Equivalent combination of education and applicable job experience may be considered.
- Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
- 7+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry, including significant CMC Regulatory Affairs experience.
- Demonstrated experience supporting biologics development programs from early development through commercialization.
- Significant experience supporting Phase 3 and late-stage development programs.
- Experience supporting global regulatory submissions, including BLAs, MAAs, NDAs, INDs, IMPDs, and CTAs.
- Extensive experience leading CMC regulatory activities for biologic products, particularly monoclonal antibodies, recombinant proteins, and other therapeutic biologics.
- Experience supporting manufacturing process development and commercialization of biologic drug substances and drug products.
- Experience participating in and leading Health Authority interactions related to CMC topics.
- Experience supporting global post-approval change management, comparability assessments, process validation, and lifecycle management activities.
Additional Skills/Experience/Requirements
- The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.
- Comprehensive understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC regulatory requirements.
- Strong understanding of biologics regulatory requirements throughout product development and commercialization.
- Experience supporting products for rare diseases and/or orphan indications preferred.
- Demonstrated ability to develop and execute global CMC regulatory strategies.
- Strong knowledge of CMC development, process validation, comparability, quality systems, and lifecycle management requirements.
- Strong technical understanding of biologics drug substance manufacturing processes and downstream processing and purification technologies.
- Strong understanding of biologic drug product development including analytical methods and characterization techniques used for biologics.
- Strong understanding of critical quality attributes (CQAs), quality target product profiles (QTPPs), control strategies, and analytical comparability principles for monoclonal antibodies and recombinant protein therapeutics.
- Ability to travel up to 10% domestically and internationally.
- All positions have an essential job function to be able to perform face-to-face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
What you'll do
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 and global expansion filings.
- Lead CMC-related Health Authority interactions and support agency meetings globally.
- Support inspection readiness and regulatory assessments related to manufacturing and product quality.
- Develop global regulatory filing strategies for lifecycle management activities and post-approval CMC changes, including manufacturing process changes, analytical method updates, specification revisions, site transfers, process validation, and comparability assessments.
Technical Leadership for Biologics Development
- Provide regulatory guidance and strategic input for biologics development programs, including monoclonal antibodies (mAbs), recombinant proteins, fusion proteins, and other complex biologic modalities.
- Collaborate with development and manufacturing teams to support regulatory strategies related to cell line development, upstream and downstream process development, scale-up, process validation, and commercial manufacturing.
- Evaluate regulatory impact of manufacturing changes involving microbial and mammalian cell culture processes, purification operations, formulation development, fill-finish activities, and technology transfers.
- Support development and regulatory assessment of comparability strategies for manufacturing process changes, site transfers, process improvements, and lifecycle management activities.
- Provide regulatory oversight and strategic guidance for analytical characterization programs and control strategies supporting product quality, safety, and efficacy.
- Contribute to regulatory assessment of critical quality attributes (CQAs), process parameters, control strategies, and product characterization data throughout development and commercialization.
Pay
$132,000 – $172,000 a year
Employer providedTarget Base Pay Range
$132,000.00 - $172,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Where you'll work
San Diego, CAHybridOpen in Maps (opens in a new tab)
More jobs in San Diego, CAEqual opportunity, accessibility and legal noticesTravere Therapeutics's statements, word for word
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [email protected]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Manager roles in California10 roles publishing pay
Manager roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $132,000 | — | $172,000 |
| California (middle half) | $162,125 | $167,500 | $179,125 |
| All US (middle half) | $157,000 | $171,000 | $180,750 |
This role: Travere Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Travere Therapeutics's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 51 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Regulatory submissions8
- Lab testing and methods6
- Validation and qualification4
- GMP and compliance2
- Quality systems and risk2
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Travere Therapeutics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 2
- Locations
By discipline
- Regulatory3 50%
- Quality3 50%
By level
- Director3 50%
- Manager2 33%
- Senior & Principal1 17%
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Senior Manager, CMC Regulatory Affairs (Biologics) at Travere Therapeutics
Open until filled. $132K–$172K a year, employer provided.