Regulatory Professional currently working in a Medical Device Industry for class-3 Medical Devices for US, Europe and international submissions.

Regulatory Affairs Specialist @ Preparation and submission of IDE application, PMA Annual Report, 180-day Supplements, Site-Transfer Supplement, 30-day Notices. Submission of IDE Final Report, IDE Annual Report and PAS conversations/ responses to the FDA. Helped in 510(k) preparation and compilation and working on IDE application right now. From May 2015 to Present (3 months) Maple Grove, MNIntern CMC Management and Operations @ Facilitates coordination of global CMC development teams and assist with CMO management. Worked with Manager to prepare CMC timelines, budgets, support of issue resolution and Project maintenance. Support global processes and lines of communication within global CMC sub-teams, assist with meeting coordination, preparation of agendas and meeting minutes. Review of CMO deliverable and technical documentation ( Clinical protocols, reports, IBs, CMC documentation, INDs, data summaries, batch records); provide support with the CMO contract preparation, PO, invoice processing, budget maintenance. Support maintenance of CMC database and CMC Project Management files, including CMC timelines, status reports, issue and risk registers. Preparations of Timelines of Projects and management of project Timelines/deadlines, kick-off meetings and review of related documents for the RA CMC department. Worked under Regulatory CMC Associate Director for Module-3: collection of documents from other departments, Scanning, Converting to PDF, Bookmarking and Hyperlinking required documents as instructed. Learned compilation of material for annual report preparation for a biologic under investigation and how to review IND Dossiers in the RA CMC Department. How to interpret Regulatory Responses and how to respond them back to the appropriate FDA department, making amendments in IND draft. From July 2014 to December 2014 (6 months) Edison, NJProctor @ Campus Security From May 2014 to June 2014 (2 months) Greater Boston AreaCo Op @ Preparing SOPs, editing SOPs, provide trainings to the company employees for new and edited SOPs related to Production and quality (GMP). Batch Record Review, Batch Record Submission to QA. Arranging and scheduling training curriculum and logistics and handling, documentation for production and QA. Provide Support in QA and Production Administrative works, document review and Preparation, supervising labeling and Operations and Reconciliation of the Packaging Material and Line Clearance. Participate in routine compliance support activities and in the Internal Audits. From July 2013 to December 2013 (6 months) NJQA/RA Associate @ From June 2012 to December 2012 (7 months) Ahmedabad Area, IndiaIntern @ Trained in the Regulatory Department for Labeling and Promotional material preparation and review, how to design a label and labeling guideline interpretation, how to prepare a package insert for Herbal and Generic Drugs Products. From November 2011 to January 2012 (3 months) Gujarat, India

Master's Degree, Regulatory Affairs for drugs, biologics and medical devices @ Northeastern University From 2013 to 2015 Bachelor of Pharmacy (B.Pharm.), Pharmacy, 75% @ GTU From 2008 to 2012 Sadaf Ranchadiya is skilled in: GMP, GLP, Sop, Quality Assurance, Pharmaceutical Industry, FDA, Quality System, International Clinical..., eCTD, GCP, 510 (k), PMAs, IND, ANDAs, NDA, Adverse Event Reporting, CMC Management, CMO management, Batch Records, Medical Devices, Project Management, 30-day notice, PMA, Post approval supplement, Annual Reports, IDE, IDE closure