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.