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Director Regulatory Strategy Jobs (NOW HIRING)

Rapport Therapeutics

Director, Regulatory Strategy

Boston, MA · On-site

$162K - $214K/yr

The Director of Regulatory Strategy will play a pivotal role in leading strategic regulatory initiatives for assigned drug development programs. Your Day-to-Day: * Create and implement innovative and ...

Lilly

Senior Director Regulatory Strategy

Boston, MA

$163K - $215K/yr

The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for gene-editing programs in early ...

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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 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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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.
Associate Director, Regulatory Strategy

Associate Director, Regulatory Strategy

Solid Biosciences

Charlestown, MA • On-site

$170K - $220K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 days ago

Job description

Associate Director, Regulatory Strategy – Solid Biosciences

Charlestown, MA

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.

We are seeking an Associate Director, Regulatory Strategy, to advance and execute end-to-end regulatory strategies that enable efficient program progression across all stages of development. Reporting to the Director, Regulatory Strategy, the candidate will support Solid’s regulatory strategy and process, playing an active role in agency interactions, applications, and driving innovative regulatory pathways to support gene therapy development. A motivated and agile regulatory professional who is keen to be part of a collaborative team with a goal to develop global regulatory experience in gene therapy drug development will thrive in this role.

This role will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA and is a hybrid position averaging 2-3 days per week in the office.

Key Position Responsibilities

  • Serve as an active representative of Regulatory on interdisciplinary teams internally (Clinical Study Teams, Program Teams, etc.) and with external partners (CROs, consultants).
  • Drive the development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development.
  • Collaborate with cross-functional teams to generate and refine the product development strategy and identify potential regulatory risks.
  • Lead global clinical trial applications including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
  • Drive regulatory submissions, including necessary cross-functional teams and timelines, relevant to assigned projects or programs.
  • Actively contribute to the preparation and execution of agency meetings.
  • Support development and implementation of global regulatory strategies, including identifying regulatory risks, to facilitate the progress of programs through all phases of development.
  • Actively monitor regulatory policy and intelligence and disseminate information to inform program strategy.
  • Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence.
  • Actively monitor regulatory policy and intelligence and disseminate information to teams.

Experience Requirements

  • PharmD or PhD preferred. Minimum of 6 years of experience in regulatory affairs in the biotech/pharma industry, including IND activity, global CTAs, DSURs, and agency briefing documents in US and ex-US.
    • Strong preference for candidates with prior small biotech experience.
  • Strong knowledge of US regulations and guidances pertaining to the conduct of investigational drug studies; ex-US experience highly desirable .
  • Experience in gene therapy and/or rare disease programs a plus, although not required.
  • Self-starter mentality, with the ability to independently and effectively organize and prioritize tasks to achieve established deadlines.
  • Ability to work both independently and collaboratively within project teams, committees, etc. to achieve group goals.
  • Excellent verbal and written communication skills.
  • Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks.
  • Creative problem solving and strategizing abilities.

Compensation

The base compensation range for this role is: $170,000.00 - $220,000.00

Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.

  • Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
  • 401(k) program participation with competitive company matched contributions
  • Eligibility to participate in Solid’s Employee Stock Purchase Plan
  • Mobile phone subsidy for eligible employees
  • Tuition Reimbursement
  • Vision Coverage
  • Life Insurance
  • Voluntary Pet Insurance
  • Employee Discount Program on Travel, Entertainment, and Services
  • Employee Assistance Programs
  • Daily Subsidized Lunch Delivery (onsite @ Hood Park)
  • Free Onsite Full-Service Gym (onsite @ Hood Park)
  • Employee Parking (onsite @ Hood Park)
  • 12 Observed Holidays and a winter shut down
  • 15-day PTO Policy and a 80-hour rollover YoY
  • 40-hour Sick Policy
  • 8 Hour Floating Holiday