Regulatory Jobs
Hero Gradient Background
Smiling Travere colleagues standing together under silver IMAGINE balloon letters in their office
Travere Therapeutics logo

New · posted Oct 15

Travere Therapeutics · Biotechnology

Manager, Regulatory Affairs Strategy

  • San Diego, CA
  • Hybrid
  • Full-time
  • Manager
Save
Pay$116K–$151Ka year · employer provided
EmploymentFull-time
LocationSan Diego, CAHybrid
LevelManager
FunctionRegulatory AffairsRegulatory
Deadline

Open until filled

The role

The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the implementation of global regulatory strategies from development through registration and lifecycle management activities. This role works closely with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and preparation for major regulatory milestones, including marketing applications.

The Manager serves as a key regulatory representative on assigned project teams and is responsible for driving regulatory deliverables, coordinating submission activities, and ensuring compliance with applicable regulatory requirements. This position requires strong regulatory knowledge, cross-functional collaboration, and the ability to operate effectively within a dynamic, matrixed environment.

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 Life Sciences or related field required. Equivalent combination of education and applicable job experience may be considered.
  • Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
  • 6+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
  • Experience supporting clinical-stage development programs and global regulatory submissions.
  • Working knowledge of FDA, EMA, ICH, and other applicable global regulatory requirements.
  • Experience preparing or supporting IND, CTA, and related regulatory submissions.
  • Strong understanding of drug development and regulatory requirements for late-stage development programs.
  • Experience supporting Phase 3 and late-stage development programs.
  • 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.
  • Driven, intelligent, passionate about making a difference for patients with rare diseases.
  • Understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC regulatory requirements.
  • Experience participating in Health Authority interactions preferred.
  • Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements and guidance related to clinical development and regulatory submissions.
  • Experience supporting registration planning, dossier development, lifecycle management, or post-approval regulatory activities strongly preferred.
  • Strong project management and organizational skills with the ability to manage multiple priorities simultaneously.
  • Excellent written and verbal communication skills.
  • Ability to work independently while collaborating effectively within cross-functional teams.
  • Demonstrated problem-solving skills and sound regulatory judgment.
  • 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.

Skills named in this posting

What you'll do

  1. Support implementation of global regulatory strategies for late-stage development programs and registration activities.
  2. Represent Regulatory Affairs on cross-functional project teams and provide regulatory input on development, registration, and lifecycle management activities.
  3. Coordinate preparation and submission of regulatory applications, including INDs, CTAs, amendments, annual reports, briefing packages, and marketing application components (e.g., NDA, BLA, MAA).
  4. Lead preparation of regulatory documents and collaborate with subject matter experts to support major submission milestones and dossier readiness activities.
  5. Support Health Authority interactions, including preparation of meeting requests, briefing documents, responses to agency questions, and post-meeting commitments.
  6. Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management teams to support registration planning and execution.
  7. Support regulatory submission planning, content development, timeline management, and tracking of key registration deliverables.
  8. Assist with regulatory activities related to lifecycle management, including post-approval commitments, variations, supplements, and labeling updates, as applicable.
  9. Identify regulatory risks and support development of mitigation strategies to support program objectives and timelines.
  10. Manage activities performed by regulatory consultants, contract resources, and external vendors, as appropriate.
  11. Contribute to regulatory intelligence efforts by evaluating emerging regulations, guidance documents, and precedents relevant to development and registration programs.
  12. Support development and continuous improvement of regulatory processes, templates, and best practices.
  13. Additional duties assigned as needed.

Pay

$116,000 – $151,000 a year

Employer provided
How this compares

Target Base Pay Range

$116,000.00 - $151,000.00

*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, CA
Equal 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 18% below the US median for Regulatory Affairs roles at this level.

This roleEmployer provided

$116,000 to $151,000 a year

Manager roles in California14 roles publishing pay

Middle half $159,000 to $179,500, median $171,000

Manager roles in the US47 roles publishing pay

Middle half $146,750 to $177,750, median $162,500
Annual base pay
Annual base payLowMedianHigh
This role$116,000—$151,000
California$159,000$171,000$179,500
All US$146,750$162,500$177,750

This role: Travere Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Travere Therapeutics's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $90K median34 open

  2. One step back

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $138K median69 open

  3. This role

    Manager

    Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

    $163K median59 open

  4. Next step

    Director

    Often: Director, Regulatory Affairs · Senior Director, Regulatory Affairs

    $235K median110 open

  5. Later

    VP & Executive

    Often: Vice President, Regulatory Affairs · Global Head of Injectable Aesthetics Regulatory Strategy

    $321K median18 open

Career resources on Regulatory Affairs

Skills DNA

What this role leans on

How many of the posting's 46 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 2 linesDocumentation and SOPs: 5 linesValidation and qualification: 1 lineRegulatory submissions: 12 linesQuality systems and risk: 1 lineCollaboration and leadership: 12 linesGMPDocumentationValidationSubmissionsQuality systemsTeamwork
  • Regulatory submissions12
  • Collaboration and leadership12
  • Documentation and SOPs5
  • GMP and compliance2
  • Validation and qualification1
  • Quality systems and risk1

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.

From Regulatory News

Manufacturing and quality coverage for this profession

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%
See all 6 Travere Therapeutics roles

More roles at Travere Therapeutics

All 6 Travere Therapeutics roles

Similar Regulatory Affairs roles elsewhere

Manager, Regulatory Affairs Strategy at Travere Therapeutics

Open until filled. $116K–$151K a year, employer provided.

Job alerts
    Manager, Regulatory Affairs Strategy at Travere Therapeutics — San Diego, CA | Regulatory Jobs