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Director Regulatory Intelligence Jobs (NOW HIRING)

Synchron Inc.

Senior Director, Regulatory Affairs-CA

San Diego, CA · On-site

$210K - $240K/yr

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department: Regulatory ... Regulatory Intelligence and Compliance * Monitor evolving FDA regulations, guidance documents, and ...

Travere

Director, Regulatory Affairs Strategy

San Diego, CA · On-site +1

$159K - $210K/yr

  • Medical

  • Life

  • Retirement

  • PTO

The Director, Regulatory Affairs Strategy is responsible for developing and executing global ... Regulatory Intelligence & Compliance * Monitor evolving global regulatory requirements, guidance ...

Vor Bio

Director/ Senior Director, Regulatory CMC

Boston, MA · On-site

$163K - $215K/yr

  • Medical

  • Retirement

  • PTO

... intelligence activities as they pertain to global CMC regulations and guidance and integrate into program plans. • Maintain responsibility for all CMC Regulatory timelines, that also includes ...

Morgan Stanley

Director, Regulatory Affairs

Littleton, CO · On-site

$177 - $266/hr

  • Medical

  • Retirement

  • PTO

Regulatory Intelligence & Lifecycle and Risk Management * Monitor and assess emerging regulations, standards, and guidance related to additive manufacturing, personalized devices, and digital health.

Genetix Biotherapeutics

Sr. Director, Regulatory CMC

Somerville, MA · On-site

$163K - $216K/yr

  • Medical

  • Life

  • Retirement

Position Description The Senior Director, Regulatory CMC is responsible for defining and executing ... Contribute to and lead regulatory intelligence efforts related to post-approval expectations ...

Welcome to the Tarsanet Internal Career Center!

OR · On-site

$149K - $197K/yr

  • Medical

  • Dental

  • Vision

  • PTO

About the Role The Senior Director Regulatory Affairs Strategy will play a key role in guiding ... Develop and lead regulatory intelligence gathering as well as regulatory influence management at ...

Tarsus Pharmaceuticals

OR · On-site

$149K - $197K/yr

  • Medical

  • Dental

  • Vision

  • PTO

About the Role The Senior Director Regulatory Affairs Strategy will play a key role in guiding ... Develop and lead regulatory intelligence gathering as well as regulatory influence management at ...

Tarsus Pharmaceuticals

Sr Director, Regulatory Affairs Strategy

$153K - $202K/yr

  • Medical

  • Dental

  • Vision

  • PTO

About the Role The Senior Director Regulatory Affairs Strategy will play a key role in guiding ... Develop and lead regulatory intelligence gathering as well as regulatory influence management at ...

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Director Regulatory Intelligence information

See salary details

$91K

$176.2K

$248.5K

How much do director regulatory intelligence jobs pay per year?

As of Aug 13, 2026, the average yearly pay for director regulatory intelligence in the United States is $176,150.00, according to ZipRecruiter salary data. Most workers in this role earn between $150,000.00 and $198,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a director regulatory intelligence?

To thrive as a Director of Regulatory Intelligence, you need deep expertise in regulatory affairs, strategic analysis, and industry guidelines, often backed by an advanced degree in life sciences or law. Familiarity with regulatory databases, global compliance platforms, and relevant certifications like RAC is highly beneficial. Exceptional communication, leadership, and critical thinking skills set successful candidates apart by enabling effective cross-functional collaboration and proactive risk management. These skills ensure that organizations stay ahead of regulatory changes, maintain compliance, and achieve business objectives in dynamic markets.

What is the difference between Director Regulatory Intelligence vs Regulatory Affairs Manager?

AspectDirector Regulatory IntelligenceRegulatory Affairs Manager
Required CredentialsBachelor's or Master’s in Life Sciences, Regulatory Affairs Certification (RAC)Bachelor's or Master’s in Life Sciences, Regulatory Affairs Certification (RAC)
Work EnvironmentStrategic, cross-functional teams, senior managementOperational, project management, compliance-focused
Employer & Industry UsagePharmaceutical, biotech, healthcare companiesPharmaceutical, biotech, healthcare companies
Search & Comparison IntentUnderstanding strategic regulatory rolesManaging regulatory submissions and compliance

The main difference is that the Director Regulatory Intelligence focuses on analyzing and interpreting regulatory trends to inform strategic decisions, while the Regulatory Affairs Manager handles day-to-day regulatory submissions and compliance activities. Both roles require similar credentials and are common in the pharmaceutical and biotech industries, but they differ in scope and strategic versus operational focus.

How does a director regulatory intelligence typically collaborate with cross-functional teams within an organization?

A Director of Regulatory Intelligence regularly partners with departments such as clinical, legal, quality, and R&D to interpret and communicate evolving regulatory requirements. This collaboration ensures that all functions are aligned with current global regulations and that strategic decisions are informed by the latest intelligence. Effective teamwork is critical for anticipating regulatory changes, guiding product development, and maintaining compliance across markets. Strong communication and relationship-building skills are essential, as the role often involves leading cross-functional meetings and providing actionable insights to senior leadership.

What does a director regulatory intelligence do?

A Director of Regulatory Intelligence is responsible for monitoring, analyzing, and interpreting regulatory trends, policies, and changes that could impact their organization, particularly in highly regulated industries like pharmaceuticals or medical devices. They lead teams to gather intelligence on global regulations, assess the potential impact on business strategies, and advise leadership on compliance and risk management. This role often involves liaising with regulatory agencies, developing strategies to address regulatory challenges, and ensuring the company's products and operations remain compliant with current and emerging regulations.
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What cities are hiring for Director Regulatory Intelligence jobs? Cities with the most Director Regulatory Intelligence job openings:
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Director Regulatory Intelligence jobs near you
Infographic showing various Director Regulatory Intelligence job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 9% Part Time, and 3% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Director, Regulatory Affairs Strategy

Travere Therapeutics

San Diego, CA • On-site

$161K - $213K/yr

Full-time

Medical, Life, Retirement, PTO

Re-posted 21 days ago

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 Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical development, registration, and commercialization of investigational products. This individual serves as the regulatory lead for assigned programs and provides strategic guidance to cross-functional teams, ensuring alignment with global regulatory requirements and corporate objectives.
The Director partners closely with Clinical Development, Clinical Operations, Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial, and Executive Leadership to drive regulatory excellence throughout late-stage development. The role requires extensive experience interacting with global health authorities, including the FDA, EMA, and other regulatory agencies.
Responsibilities:
Regulatory Strategy & Leadership
  • Develop and lead global regulatory strategies for Phase 2 and Phase 3 clinical development programs.
  • Provide regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways.
  • Evaluate regulatory risks and opportunities and develop mitigation strategies to support program objectives.
  • Lead regulatory planning for major milestones, including End-of-Phase 2 meetings, Scientific Advice procedures, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications.
  • Serve as the regulatory representative on cross-functional program teams and governance committees.

Health Authority Interactions
  • Lead preparation, coordination, and execution of global regulatory agency meetings and interactions.
  • Develop briefing documents, regulatory questions, meeting strategies, and response packages.
  • Represent the company during regulatory agency meetings and negotiations.
  • Ensure alignment of regulatory strategy across regions while addressing local market requirements.

Regulatory Submissions
  • Oversee the preparation and submission of global regulatory documents, including:
    • INDs and IND amendments
    • Clinical Trial Applications (CTAs)
    • Annual reports and Development Safety Update Reports (DSURs)
    • Pediatric plans and orphan drug submissions
    • NDA, BLA, MAA, and other marketing applications
  • Review and approve key submission documents to ensure regulatory compliance, scientific integrity, and strategic consistency.

Cross-Functional Collaboration
  • Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory considerations into development plans.
  • Provide regulatory leadership for label development and commercialization planning.
  • Support due diligence activities, business development initiatives, and portfolio evaluations as needed.
  • Mentor and develop regulatory staff and contribute to building organizational regulatory capabilities.

Regulatory Intelligence & Compliance
  • Monitor evolving global regulatory requirements, guidance documents, and industry trends.
  • Assess potential impact of regulatory changes on development programs and advise leadership accordingly.
  • Ensure compliance with applicable regulatory regulations, guidelines, and company procedures.

Education/Experience Requirements:
  • Bachelor's degree in a scientific or related field required. Equitable combination of skills and relevant experience are also considered
  • Advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Affairs, or related discipline preferred (PhD, PharmD, MD, or MS)
  • 10+ years of progressive regulatory affairs experience within the pharmaceutical, biotechnology, or life sciences industry
  • Significant experience leading regulatory strategy for Phase 2 and Phase 3 development programs
  • Demonstrated success managing interactions with FDA and other major global health authorities
  • Experience supporting or leading NDA, BLA, MAA, or equivalent marketing application submissions
  • Strong understanding of global drug development, regulatory frameworks, and clinical trial regulations
  • Experience in one or more therapeutic areas such as oncology, rare disease, immunology, neuroscience, or metabolic disease preferred

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
  • Exceptional communication, negotiation, and influencing skills
  • Ability to effectively manage complex regulatory issues in a fast-paced environment
  • Strong leadership and cross-functional collaboration capabilities
  • Strong strategic thinking with strong business and scientific acumen, problem-solving, and decision-making capabilities
  • Strong interpersonal and proactive approach. Able to work both independently and in a team environment
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies
  • Proven ability to manage multiple priorities in a fast-paced environment
  • Ability to work effectively across global time zones when necessary
  • Some travel (10-15%) may be required, with the potential for travel occurring over weekends
  • 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:
$189,000.00 - $246,000.00
*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 accommodations@travere.com. 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.

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