Manager, Regulatory Affairs Strategy

Regulatory Toolkit; San Diego (CA); On-site; USD 116,000 - 151,000; Full time

Job summary

Travere Therapeutics is seeking a Manager, Regulatory Affairs to lead regulatory planning and execution for late-stage development and lifecycle programs. You will coordinate global submissions, health authority interactions, and cross-functional team activities to ensure timely approvals.

The role requires strong regulatory knowledge, the ability to collaborate across functions, and experience with IND/CTA submissions and Phase 3 programs.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 6+ years of regulatory affairs experience within pharma/biotech.
• Experience supporting global regulatory submissions (IND/CTA).
• Experience with Phase 3/late-stage programs and lifecycle management.

Responsibilities

• Support global regulatory strategies for late-stage programs and registration activities.
• Represent Regulatory Affairs on cross-functional project teams; provide regulatory input.
• Coordinate preparation and submission of regulatory applications (INDs, CTAs, NDA/BLA/MAA).
• Lead preparation of regulatory documents with SMEs for major milestones.
• Support Health Authority interactions and post-meeting commitments.
• Collaborate with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and PM teams.
• Manage lifecycle management activities including post-approval changes and labeling updates.
• Identify regulatory risks and develop mitigation strategies.
• Oversee regulatory consultants and external vendors as needed.
• Contribute to regulatory intelligence and process improvements.

Skills

Regulatory knowledge

Cross-functional collaboration

Communication skills

Travel up to 10%

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

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.

Position Summary

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.

Responsibilities

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

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.

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.

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.

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.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. 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.