Eric Thostesen
Senior Director, Regulatory Compliance at Janssen, Pharmaceutical Companies of Johnson and Johnson
- Role
- Senior Director, Strategic Business Support, Regulatory Compliance at Johnson & Johnson Innovative Medicine
- Location
- Somerville, NJ, US
- LinkedIn followers
- 500 followers
About Eric Thostesen
Over 30 years of quality and cGMP in the pharmaceutical and biotech industries with…
Experience
Senior Director, Strategic Business Support, Regulatory Compliance
Johnson & Johnson Innovative Medicine
Sep 2012 — Present · Raritan, NJ, US
Provide Regulatory Compliance Direction and Expertise globally in the assessment of new business opportunities and risk mitigation strategies for new products introduction, product licensing and acquisitions. Includes the coordination of GxP Due diligence in CMC and Clinical Quality Systems.
Education
The College of New Jersey
BS, Biology
1986 — 1991
Skills
- 21 Cfr Part 11
- Design Control
- Regulatory Submissions
- Pharmaceutical Industry
- Sop
- Fda
- Strategic Business Initiatives
- Regulatory Requirements
- Management
- Ind
- Verification and Validation (V&V)
- Clinical Development
- Quality Assurance
- Hplc
- U.s. Food and Drug Administration (Fda)
- Compliance
- Iso 13485
- Validation
- Clinical Trials
- Drug Development
- Gcp
- Biopharmaceuticals
- Cross-Functional Team Leadership
- Iso 14971
- Computer System Validation
- Medical Devices
- Capa
- Biotechnology
- Good Laboratory Practice (Glp)
- Regulatory Affairs
- Lifesciences
- Recalls
- Life Sciences
- U.s. Title 21 Cfr Part 11 Regulation
- Glp
- Cleaning Validation
- Root Cause Analysis
- Change Control
- Pharmacovigilance
- High-Performance Liquid Chromatography (Hplc)
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