Sector Experience

Healthcare
Life Sciences & Pharma
9
years

Years of Experience

9/20

Member Since


Experience

 
Paradigm Bioscience Consulting Management Consulting
Senior Regulatory Affairs Advisor, Owner
01/2018 - Present
Provide regulatory strategy to bring medical devices, drugs, biologics, and
combination products to market including rare diseases and breakthrough therapies in the US and worldwide
Provide quality consulting services for Good Clinical Practices (GCPs) and Good
Manufacturing Practices (GMPs) including gap assessments, audits, TMF review and remediation, and creation of policies and procedures
Lead audits for GMP, GCLP and GCP compliance including clinical research
organizations (CROs)

Kymanox Management Consulting
Manager of Regulatory Affairs (previously Compliance Scientist), Quality + Compliance Group
01/2016 - 12/2017
- Provided regulatory and technical expertise for pre-clinical, clinical and
commercialized therapeutics (medical devices, drugs, biologics, and combinations) including those with orphan and/or fast track designation with an emphasis on remediation planning
- Authored, edited and reviewed a wide breadth of regulatory submissions (PAS, CBE, 510(k), PMA, etc.) and other regulatory documents and systems (REMS programs, CERs, etc.)