CMC Regulatory Affairs Consultant

Job Type: Contract – 12 Months
Location: Wilmington, DE – Hybrid/Onsite
Work Arrangement: 3 Days Onsite per Week – Non-Negotiable

Required Qualifications

• Bachelor''s degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.
• Strong hands-on experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Experience supporting large molecules and/or small molecules.
• Experience with IND, NDA, BLA, and/or MAA submissions.
• Experience preparing/reviewing Pre-IND/NDA/BLA meeting requests and briefing packages.
• Strong experience managing Health Authority interactions and regulatory responses.
• Experience with FDA and global Health Authorities.
• Strong understanding of CMC lifecycle management, change controls, supplements, variations, renewals, and annual reports.
• Ability to independently assess regulatory issues and provide strategic recommendations.
• Strong stakeholder management and cross-functional collaboration skills.
• Excellent written and verbal communication skills.
• Drug-device combination product experience is strongly preferred.
• Must be able to work onsite in Wilmington, Delaware 3 days per week.