Paul Kowalczyk
Senior Director Regulatory Advertising & Promotion
- Role
- Senior Director, Regulatory Advertising & Promotion at Phathom Pharmaceuticals
- Location
- East Hanover, NJ, US
- LinkedIn followers
- 500 followers
About Paul Kowalczyk
A detail-focused, results-oriented Regulatory and Quality professional with extensive and well rounded experience in both the medical device and pharmaceutical industries. Highly skilled and experienced in medical product advertising and promotion regulations, compliance and enforcement.I can be contacted at P••••••••@verizon.net
Experience
Senior Director, Regulatory Advertising & Promotion
Feb 2025 — Present
Education
Rutgers University–Newark
Bachelor of Arts (B.A.), Botany
1978 — 1982
Fairleigh Dickinson University
Executive MBA, Management
1990 — 1992
Skills
- Standard Operating Procedure (Sop)
- Quality Assurance
- Iso 13485
- Quality System
- V&V
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Gmp
- Quality Auditing
- U.s. Food and Drug Administration (Fda)
- Auditing
- Iso Standards
- Corrective and Preventive Action (Capa)
- Advertising and Promotional Material
- Verification and Validation (V&V)
- Regulatory Affairs
- Validation
- Medical Devices
- Capa
- Cross-Functional Team Leadership
- Labeling
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