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Regulatory Strategist Jobs (NOW HIRING)

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 ...

Vrtx

Regulatory Strategy Associate Director

Boston, MA · Hybrid

$168K - $252K/yr

The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will ...

Sobi

US Regulatory Strategy lead

Waltham, MA · On-site +1

The US Regulatory Strategy lead partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams including MDT and CAT, representing Regulatory on an agenda ...

Sobi

US Regulatory Strategy lead

Waltham, MA

The US Regulatory Strategy lead partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams including MDT and CAT, representing Regulatory on an agenda ...

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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Regulatory Strategist information

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How much do regulatory strategist jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for regulatory strategist in the United States is $53.66, according to ZipRecruiter salary data. Most workers in this role earn between $41.11 and $53.85 per hour, depending on experience, location, and employer.

What is a regulatory strategist?

Regulatory Strategists are professionals who help organizations navigate and comply with government regulations relevant to their industry. They develop strategies to ensure that products, services, or processes meet legal and regulatory requirements, minimizing compliance risks and facilitating successful market entry. Their work often involves interpreting complex laws, collaborating with regulatory agencies, and advising on best practices to maintain compliance while achieving business objectives.

What are some common challenges regulatory strategists face when working with cross-functional teams?

Regulatory Strategists often collaborate with diverse teams such as R&D, clinical, legal, and marketing, which can lead to challenges in aligning regulatory requirements with business objectives. Balancing compliance with innovation and speed to market requires strong communication and negotiation skills. Additionally, Regulatory Strategists must stay up-to-date on evolving regulations and effectively interpret them for non-regulatory colleagues, ensuring all departments are aligned on compliance strategies.

What are the key skills and qualifications needed to thrive as a regulatory strategist, and why are they important?

To thrive as a Regulatory Strategist, you need in-depth knowledge of regulatory frameworks, compliance standards, and industry-specific regulations, often supported by a degree in law, life sciences, or a related field. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly beneficial. Strong analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These skills ensure that organizations navigate complex regulatory landscapes successfully, minimizing risks and accelerating product approvals.

What is the difference between Regulatory Strategist vs Regulatory Affairs Specialist?

AspectRegulatory StrategistRegulatory Affairs Specialist
Required CredentialsBachelor's degree, often advanced in life sciences; certifications like RACBachelor's degree in life sciences or related field; certifications like RAC are common
Work EnvironmentStrategic planning teams, cross-functional projects, senior managementRegulatory departments, compliance teams, product development
Employer & Industry UsagePharmaceutical, biotech, medical device companies, consulting firmsPharmaceutical, biotech, medical device companies, regulatory agencies

While both roles require knowledge of regulations and certifications like RAC, Regulatory Strategists focus on developing long-term regulatory strategies and aligning them with business goals. Regulatory Affairs Specialists handle day-to-day compliance, preparing submissions, and ensuring products meet regulatory standards. The Strategist role is more planning-oriented, whereas the Specialist role is execution-focused.

More about Regulatory Strategist jobs

What states have the most Regulatory Strategist jobs?

States with the most job openings for Regulatory Strategist jobs include:

What job categories do people searching Regulatory Strategist jobs look for?

The top searched job categories for Regulatory Strategist jobs are:

Regulatory Strategist jobs near you
Infographic showing various Regulatory Strategist job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $111,611 per year, or $53.7 per hour.

Senior Director, Regulatory Strategy

Vertex Pharmaceuticals

Boston, MA • On-site

$163K - $215K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 9 days ago

Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

78th of 86 rated pharmaceutical

Job description

Job Description
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 responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional development of registered Vertex medicines, and/or (3) for the support of Vertex marketed products. This incumbent will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This roles responsibilities may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.
This is a hybrid position requiring 3 days/week onsite in our Boston or Washington, D.C office.
Key Duties & Responsibilities:
  • Leads the development of regulatory strategy for multiple and/or complex projects in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including for regulatory submission documents and Health Authority communications
  • Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy
  • Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices
  • Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time
  • Works to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and regulatory policy and intelligence including competitive issues that influence regulatory strategy.
  • Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in area of expertise
  • Leads GRA functional team(s) including participating in the skill development, coaching, and performance feedback for members of the GRA functional teams
  • As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Required Knowledge & Skills:
  • A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems
  • Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents
  • Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
  • Demonstrated technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and external environments. Expert knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use, with demonstrated knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals
  • Advanced proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products.
  • Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams.
  • Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development.
  • Ability to articulate the organization's strategic vision and core values, and successfully contribute to improving the quality of internal regulatory policies, programs and initiatives.
  • A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring.

Required Education & Experience:
  • Bachelor's degree in Biology, Chemistry, or other related discipline
  • Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience

#LI-EE1 #LI-Hybrid
Pay Range:
$232,000 - $348,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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