Principal Consultant, Regulatory CMC

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.

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.

• 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.

• 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.

• 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…