CMC Regulatory Consultant

Qualifications/Experience

• At least 8 years of CMC or quality-focused regulatory experience within the pharmaceutical industry, with prior FDA experience and/or regulatory consulting experience strongly preferred.
• Ph.D. in Chemistry, Biochemistry, or a closely related discipline, or an M.S. in a relevant scientific field with extensive experience in CMC regulatory affairs.
• Deep understanding of CMC requirements and strategy throughout the product lifecycle, including drug development and post-approval. Familiarity with ICH, FDA, EMA, and other regulatory bodies' guidelines and standards is essential.
• Regulatory Document Preparation: Experience with the preparation of regulatory submissions in CTD format, including IBs, Briefing Packages, INDs, CTAs, NDAs, and MAAs.
• CMC Strategy & Risk Management
• CMC & CMO Interaction
• FDA experience is a plus
• Experience with device regulations, combination products, or biologics is a plus.
• Experience supporting business development activities, including proposal writing and client relationship management, is a plus.
• Eligibility: Must be eligible to work in the U.S. without restrictions.

Job Duties:

• Regulatory Documentation: Write and review the CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, Investigator’s Brochures (IBs), meeting briefing packages, annual reports) and other strategic development documents (e.g., gap analyses, development plans).
• Regulatory Advisory: Advise clients on regulatory requirements from agencies like the FDA, Health Canada, and EMA. Provide regulatory guidance on drug substance and drug product quality expectations, tailored to the stage of development and eventual commercial presentation.
• CMC Strategy & Risk Assessment: Offer strategic advice regarding CMC development activities, ensuring alignment with regulatory guidelines. Evaluate CMC-related risks and support clients in developing risk mitigation strategies.
• Source Documentation & Assessment: Review source documents, manufacturing processes, raw materials, and methods used by contract manufacturing organizations (CMOs) and other partners to ensure compliance with regulatory standards.
• Cross-Functional Collaboration: Collaborate with other practice areas, such as nonclinical and clinical, to ensure integrated development strategies across the entire drug lifecycle.
• Regulatory Communication: Serve as the subject matter expert for all CMC-related inquiries, responding to regulatory agency questions, participating in teleconferences, and providing written and oral responses to regulators and clients.
• Project Management: Track project progress, manage timelines, and ensure deliverables meet client expectations. Communicate effectively with internal teams, project managers, and clients, escalating issues as needed.
• Training & Mentorship: Provide training and mentorship to internal staff, clients, and external vendors on CMC regulatory processes, best practices, and compliance standards.
• Quality Standards: Adhere to organizational quality standards, supporting or participating in quality assurance activities as required.
• Business Development: Identify opportunities for new business and contribute to growing client relationships. Support efforts to expand the organization’s CMC regulatory consulting services, including proposal preparation and scope development.