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Regulatory Strategist Jobs (NOW HIRING)

Rho Inc

CMC Regulatory Strategist

$153K - $202K/yr

As a CMC Regulatory Strategist, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical ...

Precision Point

Director of Regulatory Affairs

San Jose, CA · On-site

$175K - $232K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Alameda, CA · On-site

$174K - $229K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Santa Clara, CA · On-site

$174K - $230K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Fremont, CA · On-site

$164K - $216K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

San Mateo, CA · On-site

$170K - $225K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Sonoma, CA · On-site

$168K - $221K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Sunnyvale, CA · On-site

$178K - $235K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Santa Rosa, CA · On-site

$164K - $216K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Mundelein, IL · On-site

$153K - $202K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Precision Point

Director of Regulatory Affairs

Hayward, CA · On-site

$172K - $227K/yr

Director, Regulatory Affairs Strategy About the Rol eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

Strategic Leadership & Program Ownership * Lead and execute global CMC regulatory strategies for assigned programs across all phases of development, including IND, IMPD, BLA/MAA, and post-approval ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA

$161K - $213K/yr

The Director serves as a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk ...

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 ...

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Regulatory Strategist information

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$28

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How much do regulatory strategist jobs pay per hour?

As of Jun 16, 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 are Regulatory Strategists?

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 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.

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.
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 June 2026, with employment types broken down into 75% Full Time, and 25% Contract. Highlights an 100% In-person job distribution, with an average salary of $111,611 per year, or $53.7 per hour.
CMC Regulatory Strategist

CMC Regulatory Strategist

Rho Inc

Remote

$153K - $202K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 27 days ago

Job description

Join us in redefining what it means to work for a CRO.
When you work at Rho, it's more than just a job-you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.
Whether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work-and each other.
You'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.
We are currently hiring a CMC Regulatory Strategist to join our team! As a CMC Regulatory Strategist, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. You will serve as Rho's senior CMC expert and ensures full CMC support for Rho's project teams, including CMC-specific project tasks such as developing and tracking project budget, timelines, resources, and deliverables, as well as authoring and reviewing CMC regulatory documents for clinical trial applications and marketing applications, regulatory agency meeting packages, CMC gap analyses, and other documents as needed.
Our Regulatory Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!
Key Responsibilities:
  • On behalf of Rho's clients, support and advise the CMC and related regulatory components of integrated development programs, serve as the lead CMC author of technical documents, participation in technical discussions, and collaborations with CDMOs and other vendors.
  • Provide CMC regulatory-related leadership, guidance, and support to a team
  • Mentor and advise Rho staff in CMC regulatory strategy and product development by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
  • Proactively identify risks and critically analyze problems affecting the programs and develop contingency plans as needed
  • Facilitate achievement of strategic goals for a program
  • Monitor ongoing progress of key CMC deliverables against Global Integrated Product Development Plan goals
  • Ensure effective, accurate and timely communication of key issues and progress to the team and senior management
  • Participate in the planning, preparation, and conduct of regulatory authority meetings; lead CMC discussions with regulatory authorities
  • Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers
  • Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; provide guidance and input to the budgets and business submissions of proposals

Requirements
  • PhD/PharmD or equivalent demonstration of analytical ability and a minimum of 12 years in development programs that include inter-related clinical, nonclinical, CMC and regulatory experience
  • Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) is desired
  • Excellent regulatory intuition and project management acumen with an in-depth CMC regulatory and product development experience, and a firm understanding of the dependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory for integrated development programs across all phases from pre-phase 1 to marketing application.
  • Excellent communication skills (written, verbal, interpersonal, and presentation) and the ability to interact effectively with all levels both within and outside the company; proven ability to establish credibility with professionals on program teams; ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure
  • Ability to understand and motivate others and build effective teams•
  • Critical thinking skills with the ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
  • Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments

Benefits
Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.
As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $190,000-$210,000 per year.
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