Sheila Bello Irizarry Rac

FAQ About Sheila Bello Irizarry Rac

• What is Sheila Bello Irizarry Rac's address?

  Sheila Bello Irizarry Rac is located at Chapel Hill, North Carolina, United States

• What is Sheila Bello Irizarry Rac's job title?

  Sheila Bello Irizarry Rac is a • Highly motivated leader and regulatory strategist with more than 18 years of experience in drug development. • Vastly experienced in leading the regulatory strategy and regulatory submission programs of varying scope for multiple types of marketing applications and investigational drug applications; examples include Emergency Use Authorization (EUA)/Provisional and Conditional Authorizations, IND, CTA, NDA/BLA (initial and supplemental) and MAA submissions; • Experience with multiple regulatory designations and pathways: orphan drug designation, fast track designation, breakthrough therapy designation requests, accelerated approval pathway • Regulatory expertise in clinical and nonclinical strategy, messaging and submission content; some examples include development, review, and/or approval of briefing documents, responses to regulatory agency queries, investigator brochures, clinical protocols, general investigational plans, annual reports, among others. • Experience with GCP Inspections as Regulatory Subject Matter Expert (SME) • Regulatory advisory role in cross-functional teams consisting of Clinical Development and Operations, Nonclinical development, Biostatistics, Project Management, Regulatory Operations, Global and Regional Labeling, Medical Affairs, Data Management, among others • Diverse therapeutic area experience: biologics, drugs, immunology, infectious diseases, vaccine development, monoclonal antibodies (mAbs), rare diseases, combination products, inflammation, neuromuscular disorders, rheumatology, neurology, CNS, oncology, lung biology, gastroenterology, dermatology, hormone replacement therapy, analgesia Astrazeneca

• What industry does Sheila Bello Irizarry Rac currently work in?

  Sheila Bello Irizarry Rac currently works in the Astrazeneca

• What is Sheila Bello Irizarry Rac's area of expertise?

  Sheila Bello Irizarry Rac specializes in • Highly motivated leader and regulatory strategist with more than 18 years of experience in drug development. • Vastly experienced in leading the regulatory strategy and regulatory submission programs of varying scope for multiple types of marketing applications and investigational drug applications; examples include Emergency Use Authorization (EUA)/Provisional and Conditional Authorizations, IND, CTA, NDA/BLA (initial and supplemental) and MAA submissions; • Experience with multiple regulatory designations and pathways: orphan drug designation, fast track designation, breakthrough therapy designation requests, accelerated approval pathway • Regulatory expertise in clinical and nonclinical strategy, messaging and submission content; some examples include development, review, and/or approval of briefing documents, responses to regulatory agency queries, investigator brochures, clinical protocols, general investigational plans, annual reports, among others. • Experience with GCP Inspections as Regulatory Subject Matter Expert (SME) • Regulatory advisory role in cross-functional teams consisting of Clinical Development and Operations, Nonclinical development, Biostatistics, Project Management, Regulatory Operations, Global and Regional Labeling, Medical Affairs, Data Management, among others • Diverse therapeutic area experience: biologics, drugs, immunology, infectious diseases, vaccine development, monoclonal antibodies (mAbs), rare diseases, combination products, inflammation, neuromuscular disorders, rheumatology, neurology, CNS, oncology, lung biology, gastroenterology, dermatology, hormone replacement therapy, analgesia

• Which languages does Sheila Bello Irizarry Rac speak? 

  Sheila Bello Irizarry Rac speaks the following languages: No languages available.

• Which industries has Sheila Bello Irizarry Rac previously worked in?

  Sheila Bello Irizarry Rac has prior experience in the following industries: Novavax , Ucb , Mms , Rho , Rho , University Of Rochester Medical Center , University Of Rochester Medical Center , University Of Rochester Medical Center , Hiv Vaccine Trials Network Aids Clinical Trials Group And The Pediatric Hiv Program , University Of Rochester Medical Center , The National Institutes Of Health , Janssen Pharmaceutical Companies Of Johnson And Johnson

• What is Sheila Bello Irizarry Rac’s work experience?  

  Sheila Bello Irizarry Rac has the following professional experience: Astrazeneca , Novavax , Ucb , Mms , Rho , Rho , University Of Rochester Medical Center , University Of Rochester Medical Center , University Of Rochester Medical Center , Hiv Vaccine Trials Network Aids Clinical Trials Group And The Pediatric Hiv Program , University Of Rochester Medical Center , The National Institutes Of Health , Janssen Pharmaceutical Companies Of Johnson And Johnson .

• How can I find Sheila Bello Irizarry Rac on LinkedIn?  

  You can view Sheila Bello Irizarry Rac’s LinkedIn profile at LinkedIn URL.

• What are Sheila Bello Irizarry Rac’s work email addresses?  

  Sheila Bello Irizarry Rac’s work email addresses are [email protected] .

• What company does Sheila Bello Irizarry Rac work for?  

  Sheila Bello Irizarry Rac works at Astrazeneca