Plinio T. de Goes
- Role
- Regulatory Affairs Principal - Head at Kao EMEA & Americas
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Plinio T. de Goes
Chemical Engineer and MBA with experience in Drugs, OTCs, Medical Devices, and Consumer…
Experience
Regulatory Affairs Principal - Head
Aug 2016 — Present
Leads the Pharmaceutical Regulatory Affairs (PRA) and Pharmacovigilance function within the Safety Sciences and Regulatory Affairs group of AMRL. Responsible for: Regulatory compliance for all current and new products developed by AMRL prior to launch. Ensures that the Regulatory Compliance review processes meet the expected standards and/ or regulations for RMs and products within AMRL’s lead markets (North America, EU and Australia). Development of an overall AMRL Regulatory Strategy. Leads Regulatory Intelligence Activities for Kao mass products. Leads Product Safety initiatives with those of other regions within Kao group. Responsible for managing communications and inquiries from the FDA and other Governmental agencies relating to product compliance.
Education
Universidade Estadual de Campinas
BS, Chemical Engineer
1978 — 1981
Northwood University - DeVos Graduate School
MBA, Management
1995 — 1997
Skills
- Quality System
- Mrp
- Product Development
- Product Innovation
- Polymers
- V&V
- Cosmetic Regulations - Global
- Sop
- Regulatory Affairs
- Validation
- Fda
- Regulatory Requirements
- Raw Materials
- Cosmetics
- Glp
- Innovation Management
- Strategy
- University Teaching
- Contract Manufacturing
- Quality Auditing
- Chemistry
- Change Control
- Pharmaceutical Industry
- Decentralised Procedure - Dcp
- R&D
- Medical Devices
- Iso
- Commercialization
- Regulations
- Mutual Recognition Procedures - Mrp
- Market Development
- Personal Care
- Gmp
- Capa
- Pharma National Applications
- Fmcg
- Quality Management
- Otc Regulatory Knowledge
- Technology Transfer
- Six Sigma
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