Principal Consultant, Regulatory Strategy

Multiple Openings | Remote

Opus Regulatory’s Regulatory Strategy Practice is hiring Principal Consultants to support pharmaceutical and biotechnology clients across a variety of products, development stages, and therapeutic areas.

In this role, you will combine strategic regulatory guidance with hands-on execution, helping clients navigate complex development pathways from early development through registration and commercialization. As a senior advisor and embedded member of client teams, you will develop risk-informed regulatory strategies, lead health authority interactions, and guide decisions that align regulatory requirements with program objectives.

We welcome experienced regulatory professionals who enjoy solving complex development challenges, building trusted client relationships, and contributing directly to client success.

Key Responsibilities

• Serve as a senior regulatory advisor within client teams, providing guidance on development pathways, regulatory requirements, submissions, and health authority interactions.

• Develop and implement risk-informed regulatory strategies aligned with client objectives, scientific evidence, and program 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, establishing timelines, identifying critical dependencies, and coordinating submission activities.

• Author, review, and provide strategic oversight of 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 with FDA and other health authorities, and direct cross-functional responses to agency questions and information requests.

• Represent Regulatory Affairs on development teams, translating complex data and regulatory considerations into actionable recommendations for senior stakeholders.

• Monitor evolving regulations, guidance, and precedents, and advise clients on their implications for development and commercialization.

• Provide strategic and quality oversight of client deliverables, mentor Opus consultants, and contribute to internal tools, knowledge sharing, and best practices.

• Collaborate with colleagues across Regulatory Strategy, CMC, Labeling, and Advertising & Promotional Strategy to address client needs and identify opportunities for additional support.

Required Qualifications

• At least 10 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry or regulatory consulting, with substantial experience developing and leading regulatory strategy.

• Bachelor’s degree in a scientific, technical, or related discipline.

• Demonstrated ability to independently develop and execute regulatory strategies for complex drug or biologic development programs.

• Direct experience interacting with FDA, leading health authority meetings, and managing major regulatory submissions.

• Experience across more than one therapeutic area and multiple stages of development, including early-stage or first-in-human programs and late-stage development.

• Strong knowledge of U.S. regulatory requirements and ICH guidelines, with the ability to apply that knowledge strategically and operationally.

• Experience authoring, reviewing, and providing strategic oversight of complex regulatory documents.

• Ability to interpret complex scientific data and communicate regulatory implications clearly to technical and nontechnical stakeholders.

• Strong client-facing communication, leadership, and relationship management skills, including the ability to guide cross-functional teams and influence decisions without direct authority.

• Ability to work independently, manage competing priorities, and adapt to changing client and program needs.

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 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.