Dr. Sajna Banu

Experience

• 

  VJ Salomone Group

  Feb 2020 - now

  Regulatory Affairs Associate

  Provides regulatory input for product development to ensure compliance to regulatory requirementsfor target markets.• Develop regulatory strategies to help guide regulatory submission pathways taking into considerationregulatory requirements and country regulatory dependencies to ensure optimized sequencing forsubmissions.• Works with a cross functional team to prepare and submit regulatory submissions to regulatoryauthorities.• Assesses changes in existing products to and determines the need for new / revised licenses orregistrations.• Develops plan for timely submission of renewal registrations.• Ensures compliance with pre- and post-market product approval requirements.• Support regulatory inspections as required.• Performs a broad variety of tasks in support of product and process design Show less