[Remote] Principal Consultant, Regulatory Strategy

Note: The job is a remote job and is open to candidates in USA. Opus Regulatory is hiring Principal Consultants for its Regulatory Strategy Practice to advise pharmaceutical and biotechnology clients across products, development stages, and therapeutic areas. The role develops and executes regulatory strategies, leads health authority interactions and submissions, and provides strategic guidance to client teams from early development through registration and commercialization.

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

Skills

• 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
• 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

Benefits

• Remote role.
• Medical, dental, vision, and prescription drug coverage for benefit-eligible employees and their eligible family members.
• Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP).
• A 401(k) plan.
• A paid time off package for benefit-eligible employees, including 20 vacation days, 5 sick days, and 10 paid company holidays annually.

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