Radhika Dave
Dedicated professional with a strong background in regulatory affairs, seeking a role in the pharmaceutical industry. Aiming to ensure product compliance,safety, and operational efficiency as a Regulatory BA.
- Role
- Regulatory Content Management - Business Analyst at Organon
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Radhika Dave
Knowledge of GLPs, SOPs, GCP, USDA, and FDA regulations.• Proficient in Manufacturing, Packaging, and Documentation procedures.• Familiar with ICH guidelines, e-CTD, non e-CTD submissions, 21 CFR Part 11, EMA Guidelines,NDA, IND, ANDA, CE marks, UDI Guidelines, and Drug development life cycle processes.• Test Case Scenarios, Formal and Informal Testing
Experience
Regulatory Content Management - Business Analyst
May 2023 — Present
Collaborating with IT teams and software vendors to translate business user requirements into functional requirements.• Supporting User Acceptance Testing (UAT) activities, including script creation and coordination with business stakeholders.• Providing second-level support for user inquiries, investigating root causes and issue resolutions.• Coordinating country onboarding activities, demonstrating system functionality, and managingcontent imports.
Education
Gujarat Technological University (GTU)
Bachelor of Pharmacy (B.Pharm.), Pharmacy
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