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Regulatory Strategist Jobs (NOW HIRING)

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

$259K - $317K/yr

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

$259K - $317K/yr

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

$259K - $317K/yr

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring ...

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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.

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What states have the most Regulatory Strategist jobs?

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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 Regulatory Affairs Strategist

Advanced Regenerative Manufacturing Institute Inc

Manchester, NH • On-site

Full-time

Re-posted yesterday

Job description

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

The Impact That You Will Make

Regulatory Affairs is critical to our success. In this role, you will contribute to a strong Regulatory team, devising robust regulatory strategies for ARMI members and internal projects, while ensuring compliance to federal regulations. Products include complex biologics, devices, and combination products, with many in the preclinical and clinical spaces.

Your Role

  • Attend meetings and teleconferences with clients seeking strategic regulatory guidance
  • Provide expertise related to regulatory strategy, preclinical and clinical study design, CMC, and other topics
  • Draft and review FDA meeting request packages; attend FDA teleconferences
  • Contribute to the planning, development, organization, writing, and editing of regulatory applications for BioFabConsulting members/clients
  • Provide guidance and mentorship to more junior regulatory staff
  • Create original regulatory education materials, such as workshop content and web pages
  • Provide input and assistance on ARMI | BioFabUSA projects in the technical, education and workforce development, and membership areas on an as-needed basis
  • Continually bolster personal knowledge by studying trends and developments in regulatory affairs, participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations
  • Attend events, workshops, and meetings organized by ARMI | BioFabUSA or by ARMI members

Your Skills and Experiences

  • B.S. or B.A. degree required; degree in life sciences or engineering is required.
  • M.D., or Ph.D. is preferred
  • Minimum of 8 years of direct work experience in human medical product regulatory affairs; experience with clinical trials of drugs or biologics is preferred
  • Thorough knowledge of U.S. FDA medical product regulations, current industry practices, and experience with interpretation and application of said regulations and practices
  • Ability to influence colleagues, clients, and Institute members at all levels in the organization
  • Exceptional written and verbal communication skills
  • Proficient with Microsoft software products
  • Ability to multi-task, meet deadlines, and set priorities
  • Ability to work independently and thrive in a fast-paced, rapidly changing environment
  • Collaborative attitude, sense of curiosity, and eagerness to impact positive change
  • Commitment to quality, scientific integrity, and company mission
  • Strong analytical and proactive problem-solving skills with a strong attention to detail
  • Ability to work independently and manage competing priorities

By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.

Apply