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Regulatory Strategy Jobs (NOW HIRING)

Parexel

Regulatory Strategy Consultant

As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and ...

Parexel

Regulatory Strategy Consultant

As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and ...

DTE Energy

Regulatory Strategy Consultant

Detroit, MI · On-site

Integrate corporate, business unit, and regulatory strategies into cohesive, executable plans. Determine the impact proposed legislation and/or rulings will have toward current Company regulatory ...

DTE Energy

Regulatory Strategy Consultant

Detroit, MI · On-site

Integrate corporate, business unit, and regulatory strategies into cohesive, executable plans. Determine the impact proposed legislation and/or rulings will have toward current Company regulatory ...

ITC Holdings

Manager, Regulatory Strategy

Novi, MI · On-site

Drives formulation of regulatory strategy for engagement in transmission policy and regulatory proceedings for the company. Responsible for effectively managing relationships with internal and ...

Sobi

US Regulatory Strategy lead

Waltham, MA · On-site

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 ...

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 ...

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Regulatory Strategy information

See salary details

$40.5K

$95.4K

$138.5K

How much do regulatory strategy jobs pay per year?

As of Aug 31, 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.

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Cities with the most Regulatory Strategy job openings:

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Regulatory Strategy jobs near you
Infographic showing various Regulatory Strategy 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 $95,411 per year, or $45.9 per hour.

Principal Consultant, Regulatory Strategy

Opus Regulatory

Miami, FL

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

New

Job description

About Opus Regulatory:
For more than 30 years, Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of senior-level leaders and innovators provides project-specific contributions or ongoing support through the regulatory process. Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies. 

Role Overview

The Principal Consultant, Regulatory Strategy serves as a senior regulatory advisor to one or more clients, developing and implementing risk-informed regulatory strategies and leading regulatory activities across the product development lifecycle. The Principal Consultant builds trusted relationships with client stakeholders, provides strategic leadership to cross-functional teams, and leads interactions with regulatory authorities.

Key Responsibilities for Client Teams:

  • Serve as a senior Regulatory Affairs advisor to client teams, providing tailored guidance on development pathways, regulatory requirements, health authority interactions, submissions, and industry best practices.
  • Develop and implement risk-informed regulatory strategies aligned with each client's development objectives, program risks, and organizational needs.
  • Proactively identify regulatory issues and development risks, evaluate potential pathways, and recommend practical mitigation strategies.
  • Lead regulatory planning and execution across the product lifecycle, including development of regulatory timelines, identification of critical dependencies, and coordination of submission activities.
  • Author, review, and provide strategic oversight of key regulatory documents, including health authority meeting packages, INDs, IMPDs, NDAs, BLAs, MAAs, annual reports, DSURs, amendments, and supplements.
  • Lead preparation for and participation in meetings and other interactions with FDA, EMA, and other health authorities, as applicable.
  • Direct the development of responses to health authority questions and requests for information in collaboration with cross-functional teams.
  • Represent Regulatory Affairs on cross-functional development teams and advise senior client stakeholders on regulatory implications and decisions.
  • Monitor evolving regulatory requirements, guidance, and precedents and translate them into actionable recommendations for clients.
  • Build trusted client relationships and identify opportunities for Opus to provide additional support, as appropriate.

Key Responsibilities for the Internal Opus Team:

  • Provide strategic and quality oversight of client deliverables.
  • Mentor and support other Opus consultants.
  • Contribute to internal knowledge sharing, tools, templates, and best practices.
  • Collaborate with colleagues across Regulatory Strategy, CMC, Labeling, and Advertising and Promotion to address client needs.

Required Qualifications:

  • Bachelor's degree in a scientific, technical, or related discipline.
  • Minimum of 15 years of progressive Regulatory Affairs experience in the pharmaceutical or biotechnology industry, including at least 10 years focused on regulatory strategy. Regulatory Strategy consulting experience may be a surrogate for some industry experience.
  • Demonstrated ability to independently develop and lead regulatory strategies for complex drug and/or biologic development programs.
  • Direct experience interacting with FDA and leading health authority meetings and major regulatory submissions.
  • Experience in more than one therapeutic area.
  • Experience in more than one stage of development (early stage/FIH, late stage).
  • Strong knowledge of US and ICH regulatory requirements and the ability to apply that knowledge both strategically and operationally.
  • Experience authoring, reviewing, and providing strategic oversight of complex regulatory documents.
  • Ability to interpret complex data and communicate its regulatory implications clearly to technical and nontechnical stakeholders.
  • Strong client-facing communication, leadership, and relationship-management skills.
  • Demonstrated ability to lead cross-functional teams and influence decisions without direct authority.
  • Ability to manage multiple priorities and adapt effectively to changing client and program needs in a consulting environment.

Preferred Qualifications:

  • Advanced degree in a scientific, technical, or related discipline.
  • Direct experience interacting with EMA and other global health authorities.
  • Experience across multiple product modalities.
  • Experience mentoring other regulatory professionals.

Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.

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