Principal Consultant, CMC
Benefits
4w PTO
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About the Role:
- Support pharmaceutical and biotechnology clients across products, development stages, and therapeutic areas.
- Combine strategic regulatory guidance with hands-on execution to navigate CMC requirements.
- Build strong relationships with client stakeholders and regulatory authorities.
Key Responsibilities:
- Develop and implement global CMC submission strategies aligned with client objectives.
- Lead preparation, authoring, and review of CMC content including CTD quality summaries and Module 3.
- Support regulatory filings, meetings, and inspections with FDA and global authorities.
Qualifications:
- 10+ years of pharma or biotech experience with at least 5 years in regulatory affairs CMC.
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- Strong knowledge of global CMC requirements, eCTD structure, and lifecycle management.
Opus Regulatory
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.