Manager Quality Assurance and Regulatory Affairs

Position Summary

The Manager, Regulatory Affairs and Quality Assurance (Biologics) drives complex FDA regulatory submissions for biologic programs, from Phase 1 through marketing applications (BLA/NDA). In this role, you will build and own quality systems, translate executive strategy into compliant submissions, and provide regulatory guidance to ensure rapid product approvals. You will coordinate risk assessments balancing technical impact, patient safety, and regulatory compliance.

Primary Responsibilities

• Turn executive strategy, development priorities, and target product profiles into actionable regulatory plans and submissions.
• Apply in-depth knowledge of FDCA, PHS Act Section 351, 21 CFR, and FDA/ICH guidance to build submissions that meet current agency expectations.
• Guide cross-functional teams in preparation for pre-IND/INTERACT and FDA meeting requests (Type A/B/C/D, pre-BLA/NDA).
• Author and review CMC (Module 3), nonclinical (Modules 2.4/2.6, 4), or clinical (Modules 2.5/2.7, 5) components of regulatory submissions.
• Support RA leadership in maintaining INDs, including protocol amendments, safety reports, and change notifications.
• Prepare briefing materials, question strategies, and tracking minutes for FDA meetings.
• Draft technical responses to FDA information requests and clinical holds.
• Represent Regulatory Affairs on program teams to ensure deliverables meet regulatory requirements with the least-burdensome approaches.
• Own core quality system processes, including CAPA, nonconformance reports (NCRs), change control, and SOP management.
• Build and maintain agile quality systems that ensure compliance without slowing down our ability to deliver critical products.
• Support FDA and CDMO inspection readiness (PAI/PLI, BIMO) through mock inspections and document preparation.
• Manage and develop a team of quality and regulatory professionals as business needs require.

Qualifications

• B.S., M.S., or equivalent in Life Sciences, Pharmacy, Chemistry, Biochemistry, or Engineering (experience may substitute for education).
• 5-8 years of biotech or pharma industry experience in regulatory affairs, including Phase 1 IND through marketing application.
• Biologics experience preferred.
• Hands-on experience with eCTD and FDA ESG submissions.
• Working knowledge of FDA biologics regulations (21 CFR Parts 11, 50, 56, 58, 210/211, 312, 600-610) and ICH guidelines.
• Direct experience managing CAPA, NCR, and change control in an electronic QMS.

Knowledge, Skills, and Abilities

• Capable of operating independently and building structure where it is missing.
• Strong scientific writing and risk assessment skills, relying on evidence and data to make decisions.
• Clear, proactive communicator who adapts quickly to shifting priorities.
• Experience with CBER- or CDER-regulated biologics (monoclonal antibodies, recombinant proteins, cell/gene therapy).
• RAC certification or ASQ CQA/CQE is a plus.
• CDMO oversight and phase-appropriate GMP experience.