Remote CMC Principal Consultant - Strategic Regulatory Lead

Opus Regulatory, Inc.; Durham (NC); Remote; USD 210,000 - 300,000; Full time

Benefits offered by this job

401(k) plan

Comprehensive health benefits (medical

Dental, Vision, Prescription coverage

Life Insurance

Short-Term Disability

Employee Assistance Program (EAP)

Generous paid time off: 20 vacation, 5

10 paid company holidays

Job summary

Opus Regulatory, Inc. seeks Principal Consultants to join its CMC Practice, delivering strategic regulatory guidance and hands-on execution for development, registration, and commercialization. As embedded client team members, you will craft submission strategies, lead deliverables, and interface with client stakeholders and regulators.

You will join a team that values solving complex regulatory challenges and driving client success across diverse product types and therapeutic areas.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• Broad CMC regulatory experience across product types (small molecules, biologics, etc.).
• Strong knowledge of global CMC regulatory requirements, submission pathways, eCTD, and lifecycle management.

Responsibilities

• Serve as a CMC regulatory expert for development and commercial programs, guiding strategy and addressing regulatory risks.
• Develop and implement global CMC submission strategies aligned with client objectives and regulatory requirements.
• Lead preparation, authoring, and review of CMC submission content (CTD Module 2 summaries, Module 3 sections).
• Provide strategic input for regulatory filings (INDs, NDAs, BLAs, MAAs, amendments, supplements).
• Lead CMC preparation for FDA and global regulatory meetings with materials and team coordination.

Skills

CMC regulatory expertise

Strategic guidance

Regulatory submissions

Project management

Communication

Education

Bachelor’s degree in a scientific discipline

Advanced scientific degree preferred

Job description

Opus Regulatory, Inc. seeks Principal Consultants to join its CMC Practice, delivering strategic regulatory guidance and hands-on execution for development, registration, and commercialization. As embedded client team members, you will craft submission strategies, lead deliverables, and interface with client stakeholders and regulators.

You will join a team that values solving complex regulatory challenges and driving client success across diverse product types and therapeutic areas.