Amey C.

About Amey C.

Knowledge and understanding of the regulatory pathway and strategy preparation and well versed with the submission of IND, NDA, ANDA, BLA, CTD, eCTD, IDE, 510(k), PMA and technical files.Expert knowledge of ICH, CFR, MDD, MDR, IVDR and global regulatory guidelines · Knowledge on the guidelines for ISO 9001, ISO 13485, ISO 14971, CE marking, USFDA, and CTD/eCTD dossier preparation-Experienced in governing Non-Conformances, CAPAs, CMC, GXP, CCMS, Project Management-Self-starter, motivated, and a team player with the ability to learn and apply regulations relevant to drugs, medical devices, biologics, and combination products-Knowledge of MS Office, MS Outlook, MS Project, Adobe, Sharepoint -SME in Regulatory Affairs and Quality Operations-Sound understanding of all the things related to CAPA, deviations, Change control, Non-conformances, GEMBAs-Understanding of regulatory landscapes across various countries-Experience in communicating with regulatory agencies around the world including USFDA, EU, CFDA, TGA, ANVISA, COFEPRIS, PMDA, Health Canada, HSA, CDSCO etc-Preparedness for the frequently changing regulations -Knowledge of the importance of quality and standardization -Project Management Skills – Regulatory Projects & Healthcare Projects -Demonstrated strong planning and problem-solving skills -Good organizational and time management skills; ability to adhere to timelines -Good knowledge Global Regulatory Affairs Procedures -Thorough knowledge of Risk/Compliance/Audit competencies -Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, governmental regulations -Strong process facilitation, project management, and analytical skills -Very strong attention to detail -Excellent communication and team leadership skills with strong managerial skills -Excellent writing, communication, and interpretive skills-Other skills: Structured Product Labeling (SPL), pharmaREADY, pharma soft, design controls-Systems – Phenix, Track-wise, Extedo, EDMS, MasterControl, LMS, LIMS, ERP. SAP

Experience

1. Senior Regulatory Affairs Associate

   QuidelOrtho

   Apr 2022 — Present

Education

• Harrisburg University of Science and Technology

  Master of Science - MS, Project Management

• Northeastern University

  Master of Science (MS), Regulatory Affairs in Drugs, Biologics and Medical Devices

  2017 — 2018

• University of Mumbai

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2011 — 2015