Danielle Klausman
Regulatory Affairs Consultant
- Role
- Regulatory Affairs Professionals Society (RAPS)
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Danielle Klausman
Regulatory Affairs professional with expertise in emerging biotech, big pharma, and consulting. Experienced with programs spanning various modalities and therapeutic areas from pre-clinical through post-approval in the US and abroad. Successful in preparing teams for global Health Authority interactions. Recognized by colleagues for strong communication skills in leading cross-functional teams and managing direct reports. Acknowledged for and passionate about identifying opportunities for process improvements and implementing impactful changes. Motivates teams by demonstrating a sincere passion to transform patients’ lives. Engages enthusiastically in interdisciplinary teams to achieve success together.
Experience
Regulatory Affairs Professionals Society (RAPS)
Sep 2024 — Present
Assessment development (eg, Foundation in Regulatory Affairs credential, Global Strategy certification)
Education
Carnegie Mellon University
Bachelor of Science (BS), Chemistry
Skills
- Gas Chromatography
- Analytical Chemistry
- Uv/Vis Spectroscopy
- Chromeleon
- Particle Size Analysis
- Chemstation
- Laboratory
- Dissolution Testing
- Omnic
- Empower
- Raman
- Analytical Method Validation
- High-Performance Liquid Chromatography (Hplc)
- Research and Development (R&D)
- R&D
- Method Development
- Hplc
- Research
- Tga
- Employee Training
- Accelrys Electronic Lab Notebook
- Method Transfer
- Particle Morphology
- Karl Fisher
- Ir
- Data Analysis
- Gxp
- Chemistry
- Uv/Vis
- Pfge
- Lc-Ms
- Pcr
- Stability Studies
- Pharmaceutical Industry
- Dna Sequencing
- Uplc
- Microbiology
- Electronic Lab Notebooks
- Pharmaceutical Research
- Validation
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