Associate Director, Bioanalysis & GLP Regulatory Submissions

Revelation Biosciences Inc.; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Revelation Biosciences, Inc. is seeking an Associate Director of Biology to lead GLP-regulated bioanalytical activities supporting nonclinical and clinical studies.

The role emphasizes design and execution of bioanalytical assays, biomarker identification, and collaboration with cross-functional teams for regulatory submissions. The candidate should have extensive GLP experience, familiarity with FDA/EMA submissions, and a track record of managing CROs and multi-project workflows in a biotech

Qualifications

• Experience designing and validating bioanalytical assays for PK/PD; familiarity with GLP
• Proven track record managing GLP-compliant CROs and coordinating with regulatory submissions
• Understanding GMP/GLP/GCP requirements and data integrity in nonclinical and clinical programs

Responsibilities

• Direct daily operations for development and validation of bioanalytical assays for PK, TK, and PD.
• Support biology efforts with high-quality documentation and bioanalytical reports for regulatory submissions.
• Partner with nonclinical and clinical pharmacology for PK/PD modeling activities.
• Collaborate with CMC, nonclinical, and clinical teams to identify biomarkers and support target validation.
• Identify and manage specialized bioanalytical vendors, CROs, and collaborators.
• Present assay results and recommendations to relevant groups with clarity and precision.
• Ensure data integrity and regulatory compliance (GLP/GMP/SEND) across studies.
• Contribute bioanalytical sections to regulatory submissions (IB, CTD) as needed.
• Support budgeting and forecasting within the department.

Skills

Bioanalytical assay development

GLP-regulated CRO management

PK/TK/PD modeling

Regulatory submissions

Pharmacology data interpretation

Project management

Communication skills

Education

Bachelor's degree in Biology

10+ years in regulated GLP analysis

Job description

Revelation Biosciences, Inc. is seeking an Associate Director of Biology to lead GLP-regulated bioanalytical activities supporting nonclinical and clinical studies.

The role emphasizes design and execution of bioanalytical assays, biomarker identification, and collaboration with cross-functional teams for regulatory submissions. The candidate should have extensive GLP experience, familiarity with FDA/EMA submissions, and a track record of managing CROs and multi-project workflows in a biotech