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 CMC serves as a senior regulatory advisor to one or more clients, developing and implementing risk-informed CMC regulatory strategies across the product lifecycle. The Principal Consultant provides strategic leadership for CMC development and submissions, guides cross-functional technical teams, leads CMC interactions with health authorities, and builds trusted relationships with client stakeholders.
Key Responsibilities for Client Teams:
- Serve as a senior Regulatory CMC advisor to client teams, providing tailored guidance on CMC development, manufacturing, analytical and control strategies, regulatory submissions, and health authority interactions.
- Develop and implement risk-informed CMC regulatory strategies aligned with each client’s product development, commercialization objectives, program risks, and organizational needs.
- Translate technical data, development decisions, and manufacturing changes into clear regulatory strategies and submission plans.
- Proactively identify CMC regulatory risks, gaps, and critical dependencies and recommend practical mitigation strategies.
- Lead CMC regulatory planning and content strategy for health authority meeting packages, INDs, IMPDs, NDAs, BLAs, MAAs, amendments, annual reports, supplements, and variations.
- Author, review, and provide strategic oversight of Module 3 content and other complex CMC regulatory and technical documents.
- Lead preparation for and participation in CMC 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 technical teams.
- Advise clients on comparability, change management, regulatory commitments, CMC compliance, and post-approval lifecycle strategies.
- Represent Regulatory CMC on cross-functional teams and partner effectively with Process Development, Manufacturing, Analytical Development, Quality, Supply Chain, and other functions.
- Monitor evolving CMC 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, engineering, or related discipline.
- Minimum of 15 years of progressive pharmaceutical or biotechnology industry experience, including at least 10 years focused on Regulatory CMC. Regulatory CMC consulting experience may be a surrogate for some industry experience.
- Demonstrated ability to independently develop and lead CMC regulatory strategies for complex drug and/or biologic development programs.
- Direct experience interacting with FDA and leading CMC health authority meetings and major regulatory submissions.
- Experience across at least two product modalities, such as small molecules, monoclonal antibodies, conjugates, vaccines, cell therapies, or gene therapies.
- Strong knowledge of US and ICH CMC regulatory requirements, CTD structure, and the ability to apply that knowledge both strategically and operationally.
- Experience authoring, reviewing, and providing strategic oversight of Module 3 content and other complex CMC regulatory and technical 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, engineering, or related discipline.
- Direct experience interacting with EMA and other global health authorities.
- Experience with combination products.
- Experience spanning early development, marketing applications, and post-approval lifecycle management.
- Experience mentoring other Regulatory CMC 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.