Claudia Fehling
Senior Director, Regulatory at Nimbus Therapeutics
- Role
- Senior Director, Regulatory Affairs at Nimbus Therapeutics
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Claudia Fehling
Accomplished regulatory affairs professional with 17 years of drug, biologic, and medical device regulatory experience• Regulatory Strategy Lead for INDs and CTAs and skilled in developing regulatory strategies to accelerate and de-risk product development• Guides strategic interactions and negotiations with Health Authorities• Successfully filed approximately 20 clinical trial applications (IND, CTA, or CTN), led approximately 30 health authority meetings, and filed Orphan Drug Designation (EU and US) and/or Fast Track Designation for over 15 products• Extensive experience with Orphan Drug and rare disease development programs as well as expedited development designations (Fast Track, Breakthrough Therapy, and Accelerated Approval Endpoints)• Experience spans small molecules, oligonucleotides, mAbs, therapeutic proteins, live biotherapeutics, vaccines, medical devices, and combination products across indications including neurology, oncology, immunology, antiviral, hepatology, gastroenterology, pulmonary, nephrology, endocrinology, metabolism, musculoskeletal, and urology
Experience
Senior Director, Regulatory Affairs
Nov 2024 — Present · Boston, MA, US
Education
Davidson College
BS, Biology
Johns Hopkins Bloomberg School of Public Health
Master of Public Health (MPH)
Skills
- Clinical Trials
- Quality System
- Pharmaceutical Industry
- Sop
- Fda
- Science
- Quality Control
- Gmp
- Regulatory Requirements
- Quality Assurance
- Glp
- Oncology
- Gcp
- Biopharmaceuticals
- U.s. Food and Drug Administration (Fda)
- Healthcare
- Biotechnology
- Regulatory Submissions
- Clinical Development
- Technology Transfer
- Gxp
- Life Sciences
- Quality Auditing
- 21 Cfr Part 11
- Medical Devices
- Clinical Research
- Iso 13485
- Regulatory Affairs
- Lifesciences
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