Experience

Madagoni LLC

• United States
• Staffing and Recruiting
• 1 - 100 Employee

• Sr Regulatory affairs consultant

  • Sep 2022 - Present

  • Responsible for providing Chemistry, Manufacturing, and Controls (CMC) support to ANDA’s. • Supporting outline activities include dossier development for ANDA applications, amendments, post approval variations, and other regulatory submissions. • Ensuring that all submissions are complete, accurate, and meet relevant requirements. • Managing and coordinating the authoring, reviewing, and finalization of CMC documents, and responses to CMC related inquiries from Regulatory agencies, in accordance with submission timelines. • Keeping all stakeholders, including external partners, informed of progress. • Reviewing regulatory submission documents to ensure that all submissions are complete, accurate and meet relevant requirements. Ability to work independently, prioritize, coordinate, and complete multiple projects within deadline while maintaining a high level of attention to detail is a must. • Operate as project manager and regulatory liaison for cross functional groups for periodic reports. • Knowledge of relevant drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices). • Managing external requests for data with professionalism and adherence to policy and regulations. • Maintained up-to-date knowledge of FDA standards and data requirements for different submissions. Show less



Granules India Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory affairs Sr.Executive

  • Nov 2021 - Jul 2022



Viatris

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive

  • Aug 2017 - Nov 2021



Hetero

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Officer

  • Aug 2015 - Aug 2017