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Director Regulatory Strategy Jobs (NOW HIRING)

Meet Life Sciences

Director Regulatory Affairs CMC

Sonoma, CA · Hybrid

$168K - $221K/yr

Director, Regulatory CMC (Hybrid - San Francisco Bay Area) We are partnering with a well-funded ... This is a high-impact, strategic leadership role for someone who thrives at the intersection of ...

Meet Life Sciences

Director Regulatory Affairs CMC

Alameda, CA · Hybrid

$174K - $229K/yr

Director, Regulatory CMC (Hybrid - San Francisco Bay Area) We are partnering with a well-funded ... This is a high-impact, strategic leadership role for someone who thrives at the intersection of ...

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Director, Regulatory Affairs

Blue Bell, PA · On-site

$143K - $189K/yr

We deliver global strategic regulatory consulting, dossier management services and GMP Quality services As a Director, Regulatory Affairs, you will create a culture of, process improvement with a ...

Vrtx

Regulatory Strategy Director

Boston, MA · Hybrid

$196K - $295K/yr

The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex portfolio. This ...

ICON

Director, Regulatory Affairs

Blue Bell, PA · On-site

$143K - $189K/yr

We deliver global strategic regulatory consulting, dossier management services and GMP Quality services As a Director, Regulatory Affairs, you will create a culture of, process improvement with a ...

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All JobsDirector Regulatory Strategy Jobs

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 Jun 12, 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 of 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, and why are they important?

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 of 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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What cities are hiring for Director Regulatory Strategy jobs? Cities with the most Director Regulatory Strategy job openings:
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Director Regulatory Strategy jobs near you
Infographic showing various Director Regulatory Strategy job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 90% Full Time, 6% Part Time, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.
Director, Regulatory Affairs

Director, Regulatory Affairs

Eikon Therapeutics

Jersey City, NJ

$213K - $232K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 days ago

Job description

Position

We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs. In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner. This role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs.

About You

You are a seasoned regulatory affairs professional with strong hands-on experience through clinical regulatory affairs content and strategy, and navigating FDA and international regulatory frameworks. You are comfortable operating as a senior individual contributor who leads programs through influence, partnership, and subject-matter expertise, rather than formal people management. You bring excellent communication, organizational, and problem-solving skills, and thrive in highly collaborative, fast-paced environments where you are expected to both think strategically and execute with rigor.

What You'll Do

  • Program-Focused Regulatory Leadership: Provide strategic and hands-on regulatory support across assigned clinical development programs, partnering closely with cross-functional teams to guide development and regulatory decision-making.
  • Regulatory Strategy: Contribute to the development and execution of regulatory strategies supporting product development, approval, and commercialization in alignment with company objectives.
  • Regulatory Compliance: Maintain current knowledge of evolving regulations, guidance, and industry best practices to ensure ongoing compliance across programs.
  • Submission Management: Lead and/or support the preparation, review, and submission of regulatory documents, including INDs, NDAs, and MAAs, as applicable.
  • Cross-Functional Collaboration: Work closely with Clinical Development, R&D, Quality, and other stakeholders to integrate regulatory considerations throughout the development lifecycle and drive alignment.
  • Quality Support: Support regulatory aspects of quality systems, including compliance with GCP and GLP requirements.
  • Risk Assessment: Identify regulatory risks, assess potential impact, and proactively recommend mitigation strategies.

Qualifications

  • Post-graduate degree with 10+ years of relevant regulatory affairs experience, or a Bachelor's degree with 12+ years of experience.
  • Strong working knowledge of FDA and international regulatory requirements (including regions such as EU, Japan, China) and guidelines.
  • Demonstrated experience contributing to clinical regulatory content and strategy and managing regulatory submissions.
  • Excellent written and verbal communication skills, with the ability to influence cross-functional stakeholders.
  • Strong analytical skills, attention to detail, and sound judgment.
  • Ability to thrive as an individual contributor in a dynamic, high-growth environment.
  • Prior experience supporting oncology development programs is strongly preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

  • 401k plan with company matching
  • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
  • Mental health and wellness benefits
  • Weeklong summer and winter holiday shutdowns
  • Generous paid time off and holiday policies
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
  • Enhanced parental leave benefit
  • Daily subsidized lunch program when on-site

The expected salary range for this role is $213,000 to $232,750 depending on skills, competency, and the market demand for your expertise.

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