Principal Consultant, Regulatory Strategy

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.