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Director Regulatory Strategy Jobs (NOW HIRING)

Travere

Director, Regulatory Affairs Strategy

San Diego, CA · On-site +1

$159K - $210K/yr

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 ...

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Director Regulatory Strategy information

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$91K

$176.2K

$248.5K

How much do director regulatory strategy jobs pay per year?

As of Aug 9, 2026, the average yearly pay for director regulatory strategy 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 some common challenges a director regulatory strategy may face when managing cross-functional teams during product development?

A Director of Regulatory Strategy often encounters challenges such as aligning diverse stakeholder priorities, ensuring compliance with evolving regulations, and communicating regulatory requirements effectively across departments. They must bridge gaps between R&D, clinical, legal, and commercial teams to develop cohesive strategies that accelerate product approvals while mitigating risks. Strong project management, negotiation, and communication skills are essential to overcome these obstacles and drive successful outcomes.

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

To thrive as a Director Regulatory Strategy, you generally need an advanced degree in life sciences, pharmacy, or a related field, along with significant experience in regulatory affairs and strategy development. Familiarity with regulatory submission systems, global regulatory frameworks (such as FDA, EMA, ICH), and relevant certifications like RAC are highly valuable. Strong leadership, strategic thinking, and persuasive communication skills set top performers apart in this role. These competencies are critical for navigating complex regulatory landscapes, driving successful product approvals, and aligning organizational objectives with compliance requirements.

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

AspectDirector Regulatory StrategyRegulatory Affairs Manager
CredentialsTypically requires advanced degrees (e.g., MS, PhD) and extensive industry experienceRequires relevant degrees and certifications, such as RAC or RA certifications
Work EnvironmentStrategic planning, cross-department collaboration, executive-level interactionsOperational tasks, regulatory submissions, compliance management
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for high-level strategyCommonly found in similar industries for managing regulatory processes

The main difference is that the Director Regulatory Strategy focuses on high-level strategic planning and policy development, while the Regulatory Affairs Manager handles day-to-day regulatory operations and submissions. Both roles require relevant credentials and industry experience, but the director position involves broader strategic responsibilities and leadership.

What does a director regulatory strategy do?

A Director of Regulatory Strategy is responsible for developing and implementing strategies to ensure a company's products or services comply with relevant regulations and standards. They monitor regulatory changes, advise leadership on potential impacts, and coordinate with internal teams to prepare documentation for regulatory submissions. This role often involves interacting with regulatory agencies, providing guidance during product development, and helping shape company policies to align with current and upcoming regulations. Their work is crucial in industries such as pharmaceuticals, biotechnology, medical devices, and financial services.
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Director Regulatory Strategy jobs near you
Infographic showing various Director Regulatory Strategy job openings in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 94% In-person, and 6% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)

Atsena

Durham, NC • Remote

Full-time

Re-posted 8 days ago

Job description

Job Title: Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
Department: Regulatory
Reports To: VP of Regulatory
Location: Remote or Onsite


Position Summary:

The Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) will lead global regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This individual will be responsible for developing nonclinical and clinical regulatory strategies, supporting regulatory submissions, and serving as the regulatory liaison to internal nonclinical and clinical teams.

This role requires strong experience in regulatory strategy for biologics or gene therapies and the ability to work cross-functionally with clinical development, clinical operations, nonclinical, quality and program leadership. This individual will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.


Key Responsibilities:

Regulatory Strategy Development

  • Develop and implement global regulatory strategies for gene therapy programs from preclinical through clinical development and commercialization.
  • Provide regulatory guidance on nonclinical, clinical, and translational development plans.
  • Identify regulatory risks and propose mitigation strategies to support program timelines.
  • Contribute to overall product development strategy and lifecycle planning.

Regulatory Submissions

  • Lead preparation and submission of global regulatory filings including: INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, orphan drug designation applications, Fast Track, RMAT and other expedited program submissions
  • Ensure high-quality regulatory documentation aligned with agency expectations.

Health Authority Interactions

  • Prepare regulatory briefing documents and support agency meetings.
  • Serve as a subject matter expert for interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to health authority questions and information requests.

Cross-Functional Collaboration

  • Partner closely with internal teams including: Clinical Development, Clinical Operations, Nonclinical, Quality
  • Serve as a regulatory representative on cross-functional program teams.
  • Ensure alignment of development plans with global regulatory requirements.

Regulatory Intelligence & Compliance

  • Monitor evolving regulations and guidance related to gene therapies and biologics.
  • Interpret guidance documents and communicate regulatory expectations internally.
  • Contribute to development of internal regulatory processes and best practices.


Qualifications:

Education

  • PhD, PharmD, MD or MS in life sciences, molecular biology, pharmacology, or related discipline.

Preferred Qualifications

  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience with rare disease development programs.
  • Experience with global regulatory submissions including US and EU.
  • Prior participation in regulatory agency meetings.

Associate Director Experience

  • 7–10 years of experience in regulatory affairs within biotech or pharmaceutical industry.
  • Experience supporting INDs, CTAs, and early clinical development.

Director Experience

  • 10–15+ years of experience in regulatory affairs with demonstrated leadership of regulatory strategy for development programs.
  • Proven experience leading regulatory submissions and interactions with agencies.

Knowledge & Skills

  • Strong understanding of regulatory pathways for biologics and gene therapy products.
  • Experience with nonclinical regulatory requirements for biologics.
  • Excellent regulatory writing and communication skills.
  • Ability to lead cross-functional teams and influence program strategy.
  • Strong project management and organizational skills.

Key Competencies

  • Strategic thinking and problem solving
  • Strong scientific and regulatory knowledge
  • Cross-functional leadership and collaboration
  • Clear communication and influence
  • Ability to work in a fast-paced, early-stage biotech environment