Devina Pathak Email & Phone Number

Greater Boston Area

• Explore and device a Pre-Market FDA pathway for an advanced wound care enabled device.• Align the Device development and regulatory testing plan with FDA guidances.• Assist the Director of Clinical Research in expanding and maintaining the company’s QMS as well as preparing regulatory documents for the submission to the FDA. • Deliver a strategy document and the outline for a Pre-Sub meeting with FDA to determine regulatory requirements based on the Devices’ indications of use in conjunction with FDA’s guidance criteria.

Greater Boston Area

• Assist in the preparation of ANDA and IND Annual Reports for radiopharmaceuticals. • Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols.• Research and review adverse events, clinical trials and ICFs pertaining to it. Use Excel, Word, and Project Management, to create correspondence, spreadsheets, forms, graphs, flowcharts, etc.

India

• Assist in preparation and maintenance of regulatory international submissions. • Ensure compliance with all relevant quality and regulatory/legal requirements. Review of regulatory packs/ Clinical Trial applications (CTA). Assist in the development of departmental policy and regulatory strategy. • Support QA department to assure manufacturing is performed and documented to cGMP requirements; US FDA Quality System Regulation 21 CFR 210 & 211. Perform cGMP activities to support the QA group, such as: CAPA, complaints, audits, training, labeling, etc.

Master’S Degree, Drug And Regulatory Affairs

Bachelor'S Degree, Pharmacy

Activities and Societies: Nirma Institute of Pharmacy Student's Association