Sanjitha G

Regulatory Specialist @Larsen & Toubro

Bengaluru, IN

Experience in working in e-CTD and CTD submission.• Experience in Author and/or review regulatory procedures and update as necessary.• Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.• Review change control documents and ascertain regulatory impact for external and internal documents through formalregulatory assessments.• Prepare, review, file, and support premarket documents for global registrations for assigned projects• Experience in Technical file Remediation, Regulatory Plan, DHF and DMR Remediation.• Good understanding for regulations and policies issued by US FDA and EU, and ability to interpret international regulatoryrequirements.• Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.• Working Knowledge of Engineering standard like ISO13485/9001, ISO 14971, FDA 21 CFR, EU MDR and QMS etc.