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Regulatory Strategy Jobs (NOW HIRING)

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

Develop regulatory trend analyses and strategic impact assessments for business leadership. * Lead or contribute to quarterly regulatory outlook reports and regulatory intelligence publications.

Posted today

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Regulatory Strategy information

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$40.5K

$95.4K

$138.5K

How much do regulatory strategy jobs pay per year?

As of Sep 11, 2026, the average yearly pay for regulatory strategy in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

What is regulatory strategy?

Regulatory strategy refers to the planning and management of processes to ensure that a company's products or services comply with applicable laws, regulations, and industry standards. This often involves working with regulatory agencies, preparing and submitting documentation, and staying updated on regulatory changes that could impact the business. Professionals in regulatory strategy play a critical role in guiding companies through approval processes, minimizing compliance risks, and ensuring timely entry into markets. Their expertise helps organizations navigate complex regulatory landscapes efficiently and effectively.

What are the key skills and qualifications needed to thrive in regulatory strategy?

Success in Regulatory Strategy requires a strong understanding of regulatory frameworks, compliance processes, and strategic planning, often supported by a degree in life sciences, law, or a related field. Familiarity with regulatory submission systems, databases, and certifications like RAC (Regulatory Affairs Certification) is common. Excellent analytical thinking, communication, and negotiation skills set outstanding professionals apart in this field. These competencies are crucial for ensuring that products meet regulatory requirements efficiently, enabling timely market access and reducing compliance risks.

What are some common challenges faced in a regulatory strategy role, and how can they be addressed?

Professionals in Regulatory Strategy often navigate complex and evolving regulatory environments, which can make it challenging to keep up with changing requirements across multiple regions. Balancing business goals with regulatory compliance sometimes requires creative problem-solving and effective stakeholder communication. To address these challenges, it's important to stay informed through continual training, foster strong relationships with regulatory authorities, and collaborate closely with cross-functional teams such as R&D, legal, and quality assurance. This proactive approach helps ensure that strategic objectives are met while maintaining compliance.

What is the difference between Regulatory Strategy vs Regulatory Affairs?

AspectRegulatory StrategyRegulatory Affairs
Primary FocusDeveloping long-term plans to meet regulatory requirements and facilitate product approvalManaging day-to-day regulatory submissions, compliance, and communication with authorities
Work EnvironmentStrategic planning, cross-functional collaboration, market entry planningDocumentation, submission management, regulatory compliance activities
Required CredentialsTypically advanced degrees in life sciences, regulatory affairs certificationsSimilar credentials, often with regulatory affairs certifications

Regulatory Strategy focuses on planning and aligning regulatory pathways for product approval, while Regulatory Affairs handles the execution of these plans through submissions and compliance activities. Both roles require similar qualifications but differ in scope and daily responsibilities.

More about Regulatory Strategy jobs

What cities are hiring for Regulatory Strategy jobs?

Cities with the most Regulatory Strategy job openings:

What are the most commonly searched types of Regulatory Strategy jobs?

The most popular types of Regulatory Strategy jobs are:

What states have the most Regulatory Strategy jobs?

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

Infographic showing various Regulatory Strategy job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 2% As Needed, 86% Full Time, 9% Part Time, and 2% Contract. Highlights an 85% Physical, 3% Hybrid, and 12% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Sr. Specialist, Regulatory Strategy

San Diego, CA • On-site

Scorpion Therapeutics
51 - 200 employees

Other

Posted 10 days ago


Job description

About the Role

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies, including internal audits and inspections. Compiles materials for submissions, license renewal, and annual registrations. Generates, maintains, monitors, and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Maintains and tracks timelines for regulatory deliverables. Recommends strategies for earliest possible approvals of clinical trial applications. May act as Regulatory Strategy department contact for internal projects.

Your Contributions (include, but are not limited to)
  • Prepare submissions to regulatory authorities (e.g., clinical trial applications, IND/IND supporting documents, maintenance submissions, annual reports, expedited safety reports)
  • Review clinical regulatory documents; perform quality checks of submission documentation and publishing output
  • Update and maintain logs, databases, and catalogues of regulatory compliance information
  • Coordinate review/revision procedures, specifications, and forms
  • Compile regulatory filing documents and maintain computerized files
  • Serve as Regulatory Strategy contact for internal projects/program activities
  • Initiate and maintain Smartsheet tools for timeline/submission deliverables tracking and program plans
  • Ensure quality, consistency, completeness, and accuracy of submissions
  • Review investigator packages and authorize drug shipments to clinical sites
  • Perform other assigned duties
Requirements
  • BS/BA + 4+ years relevant experience, or Master’s + 2+ years, or JD/PharmD/PhD with no experience
  • Strong understanding of regulatory documents, FDA regulations, and ICH guidelines
  • Thorough understanding of laws/standards/guidance governing drug development (US regulatory knowledge)
  • Demonstrated knowledge of US FDA and Ex-US ICH guidelines
  • Excellent computer skills; strong communications, problem-solving, analytical, and project management skills
  • Detail oriented; ability to meet multiple deadlines with accuracy and efficiency; ability to interpret/apply company standards and regulatory guidance
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