Sandra Reis

Biography

Sandra Reis is a skilled Regulatory Affairs Professional who is proficient in the development and execution of regulatory strategies and the preparation of high quality regulatory submissions, resulting in the reduction of product time-to-market. Specific capabilities include preparation, compilation, and submission of regulatory filings (i.e. INDs, CTAs, NDAs/NDSs, DMFs, ANDAs/ANDSs, 510(k), NHP Product Licensing); interacting and negotiating with Regulatory Authorities on behalf of clients; providing guidance on the regulatory aspects of product life-cycle management (from early development through to commercialization and beyond); and advising on regulatory risks associated with promotional activities. Sandra graduated with a degree in Biology, obtained a post-graduate diploma in Regulatory Affairs & Quality Operations and has completed numerous additional seminars and certifications on topics including Preparing Global Regulatory Strategies, Conduct of Clinical Trials, Electronic Submissions, Streamlining the Regulatory Process, and Promotion, Compliance & Enforcement. Sandra's specific industry experience includes: Sandra Reis is a skilled Regulatory Affairs Professional who is proficient in the development and execution of regulatory strategies and the preparation of high quality regulatory submissions, resulting in the reduction of product time-to-market. Specific capabilities include preparation, compilation, and submission of regulatory filings (i.e. INDs, CTAs, NDAs/NDSs, DMFs, ANDAs/ANDSs, 510(k), NHP Product Licensing); interacting and negotiating with Regulatory Authorities on behalf of clients; providing guidance on the regulatory aspects of product life-cycle management (from early development through to commercialization and beyond); and advising on regulatory risks associated with promotional activities. Sandra graduated with a degree in Biology, obtained a post-graduate diploma in Regulatory Affairs & Quality Operations and has completed numerous additional seminars and certifications on topics including Preparing Global Regulatory Strategies, Conduct of Clinical Trials, Electronic Submissions, Streamlining the Regulatory Process, and Promotion, Compliance & Enforcement. Sandra's specific industry experience includes:

Research Interest

Pharmaceutical Analysis and Quality Assurance  Industrial Pharmacy Clinical Pharmacy  Pharmaceutical Administration Medicinal Chemistry  Drug Discovery and Development