Timothy H. Umphlett
Regulatory Affairs Associate, Clinical stage biotechnology
San Diego, CA · (858) 555 0117 · name@example.com · linkedin.com/in/timothyhumphlett
Key Qualifications
EXPERIENCE
Three years supporting investigational new drug applications and amendments
INDUSTRIES
Clinical stage biotechnology, oncology and immunology programs
SPECIALTIES
Document compilation, common technical document formatting, commitment tracking
SYSTEMS
Veeva Vault, Microsoft Word, Adobe Acrobat, Smartsheet
CREDENTIALS
Member of the Regulatory Affairs Professionals Society
EDUCATION
Bachelor of science in biochemistry, University of California, San Diego
Executive Summary
Regulatory affairs associate with three years at a clinical stage biotechnology company. Compiles and formats sections of investigational new drug applications, tracks commitments to the Food and Drug Administration, and keeps the submission archive current. Works under a regulatory affairs manager who owns agency correspondence.
Signature Achievements
- Compiled module 2 and module 5 content for two original investigational new drug applications, both accepted with the study allowed to start after thirty days.
- Formatted and quality checked 46 protocol amendments and safety reports with no rejected submission sequences.
- Built a commitment tracker that lists every agency request and its due date, which ended the last minute scramble before each reporting cycle.
- Cut the time to assemble an annual report from four weeks to nine days by collecting source documents on a rolling basis.
- Trained six clinical operations staff on how to supply documents in the format the publishing team needs.
Professional Experience
Regulatory Affairs Associate
Torrey Pines Therapeutics, San Diego, CA 2023 to present
Supports two oncology programs in phase one and phase two for a company of 90 people.
- Assembles and formats sections of investigational new drug applications and amendments for manager review.
- Maintains the regulatory document archive in Veeva Vault and controls version history.
- Tracks agency commitments, information requests and internal due dates.
- Drafts cover letters and administrative forms and routes them for signature.
- Coordinates with clinical, nonclinical and manufacturing colleagues to collect source content.
Regulatory Affairs Assistant
Sorrento Mesa Bioscience, San Diego, CA 2022 to 2023
First regulatory role at a small company with one program in preclinical development.
- Filed and indexed correspondence with the Food and Drug Administration.
- Prepared meeting materials and took minutes at internal regulatory strategy sessions.
- Checked documents against the publishing style guide before handoff.
Licensure and Certification
Member, Regulatory Affairs Professionals Society
Education
Bachelor of science in biochemistry, University of California, San Diego
Certificate in regulatory affairs, University of California San Diego Extension
Core Skills
Investigational new drug application support · Common technical document formatting · Veeva Vault · Document quality control · Commitment tracking · Annual report preparation · Regulatory archiving · Cross team coordination · Protocol amendments · Style guide compliance