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Director Regulatory Strategy Jobs (NOW HIRING)

Vrtx

Director, Regulatory Strategy

Washington, DC · 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 ...

Vrtx

Director, Regulatory Strategy

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 ...

Vrtx

Senior Director, Regulatory Strategy

Boston, MA · Hybrid

$163K - $215K/yr

The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be ...

Vrtx

Senior Director, Regulatory Strategy

Washington, DC · Hybrid

$169K - $224K/yr

The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be ...

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$91K

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$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, Regulatory Strategy

Kardigan

South San Francisco, CA

Full-time

Re-posted 28 days ago

Job description

Position Title: Associate Director, Regulatory Strategy

Reports To: Executive Director, Regulatory

Department: Regulatory

Location: South San Francisco, CA or Princeton, NJ - On site 4 days a week (Mon to Thurs)

Job Overview

Reporting to the Executive Director, Regulatory, the Associate Director, Regulatory Strategy supports the development and execution of regulatory strategies and contributes to the planning, coordination, and preparation of regulatory submissions. This role collaborates cross-functionally to ensure high-quality regulatory deliverables while operating with moderate independence and with oversight on complex deliverables.

Essential Duties and Responsibilities

  • Contribute to the development and implementation of regulatory strategies for assigned development programs, with guidance from senior leadership
  • Demonstrated ability to operate with increasing independence while seeking guidance on complex strategic decisions
  • Plan, coordinate, and contribute to the preparation, review, and compilation of regulatory submissions in eCTD format
  • Lead or support preparation of components of submissions (e.g., Module 1-5 sections) for health authorities (FDA, EMA, and global agencies)
  • Review key documents (e.g., protocols, ICFs, IBs, CSRs, DSURs) to ensure alignment with regulatory strategy and compliance with applicable regulations and guidance
  • Track submission timelines and deliverables to support on-time execution
  • Provide regulatory input to cross-functional teams (Clinical, CMC, Nonclinical, Quality) on regulatory requirements and expectations
  • Identify regulatory risks and propose mitigation strategies for review by Regulatory leadership
  • Maintain awareness of evolving regulatory requirements and guidance (FDA, EMA, ICH, and global regulations)
  • Ensure assigned activities comply with applicable regulatory standards and company procedures
  • Support the development and review of SOPs, work instructions, and regulatory templates

Qualifications and Preferred Skills

  • Bachelor's degree required (life sciences preferred); advanced degree (MS, PhD, or PharmD) is a plus
  • Minimum of 6 years of relevant experience including roles in regulatory affairs within biotechnology or pharmaceuticals
  • Experience supporting regulatory submissions (e.g., INDs/CTAs, amendments, annual reports, or marketing applications)
  • Working knowledge of global regulatory requirements (FDA, EMA, ICH guidelines)
  • Experience contributing to or leading eCTD submissions
  • Strong organizational skills and attention to detail with the ability to manage multiple priorities
  • Effective communication skills and ability to work collaboratively in cross-functional teams
  • Ability to communicate regulatory expectations pertaining to the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams

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