Ron Jankowski
- Role
- Vice President, Regulatory and Scientific Affairs at Cook MyoSite
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Ron Jankowski
Broad experience in biologic drug development activities comprising regulatory, clinical,…
Experience
Vice President, Regulatory and Scientific Affairs
Nov 2021 — Present
Strategic guidance, management and operations of directorates comprising:o Clinical development – clinical affairs, clinical research science, and pharmacovigilance o Product development – pre-clinical, process and analytical method development (CMC)o Regulatory Affairs – strategy, operations, submissions (IND, CTA), regulatory science- Establish and lead the global regulatory and clinical strategy for all therapeutic development programs (4 Phase trials across global footprint, including: US, Europe, Canada), including submission/attainment of regulatory designations (RMAT, ILAP, orphan)- Integrate and coordinate development strategy with key internal stakeholders such as Business Development, Quality, and Manufacturing to support commercial preparation- Provide direct technical and regulatory input in preparation for global regulatory approval submissions (BLA, MAA, NOC)- Provide ongoing assessment of internal capabilities within functional units, short and long-term resource allocation, budget management and continuous improvement initiatives
Skills
- Biochemistry
- Stem Cells
- Medical Devices
- Biomedical Engineering
- Immunology
- Cell
- Medical Imaging
- Assay Development
- Regenerative Medicine
- Biotechnology
- In Vivo
- Cell Culture
- Drug Discovery
- Clinical Development
- Biomaterials
- Commercialization
- Life Sciences
- Clinical Research
- Lifesciences
- R&D
- Tissue Engineering
- Fda
- Cell Biology
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