Mobile number: 312-***-**** firstname.lastname@example.org https://www.linkedin.com/in/sheemahkazi
Master of Science - Drug Regulatory Affairs CGPA:3.8/4.0 Expected Jun.2016
Northeastern University, Boston, MA
Bachelor of Pharmacy - June 2014
Gujarat Technological University
Proficient with FDA and ICH regulation and guidance document for regulatory submissions of investigational new drug and new drug applications
Implementation of 45 CFR 46 in enrolling patients to clinical studies, bill of rights, IRB concerns, ethical issues for consent
Skilled with FDA’s Quality System Regulations, ICH & ISO 13485, cGMP (21 CFR 210 & 211 21 CFR 820.198 and 21 CFR 822 – Post Market Surveillance and guidelines necessary to ensure compliance
Strong knowledge and understanding of REMS policies & procedures, FAERS, filing of eCTD and paper based submissions, 510 (k)/ IDE filing and IND, NDA/BLA, ANDA as well CAPA
Proficient with the regulations and Guidance’s of European Medical Agency (EMA), EU design dossier & technical files, Canada and Latin America regulations.
Strong working knowledge of 93/42/EEC and 98/79/EC (IVDD) European Medical Device Directive
Ability to prepare and review CTA (Clinical Trial Applications) & Device Master File (DMF)
Through with the regulatory requirement and development of IVD’s
Excellent verbal and communication skills. Familiar with Microsoft suite and online research
Gujarat Medicraft Pvt. Ltd
Intern Regulatory Affairs May-Nov. 2014
Actively participated in renewal activities of product registrations and manufacturing licenses
Assisted in labeling changes, extension/deletion in indications
Reviewed and updated SOPs for Pharmaceutical operations and equipment’s
Confirmed to cGMP compliance in solid and liquid Manufacturing for non-sterile drugs were followed
Co-ordinated with the Quality Assurance(QA) and Quality Control (QC) department
Assisted in the annual audit conducted by CDCSCO.
Medical Device (Pre-Market Approval): Feb. 2015
Prepared PMA for medical device identifying submission type for PMA for given device description to reflect better understanding of 21 CFR 814.
New Drug Development (New Drug Application): Apr. 2015
Submitted ‘Initial IND’ and ‘New Drug Application’ for fictitious company to reflect better understanding of requirements set forth in 21 CFR 312 & 21 CFR 314.
Informed Consent Form and Clinical Protocol Apr. 2015
Developed an Informed consent form for the drug as well as clinical protocol which included dose escalation as well trail design.
Biologic License Application (BLA) Jun. 2015
Prepared BLA for a given drug considering the CFR concerning to BLA .i.e. 21 CFR 600,601 and 610, of a fictitious company to reflect improved understanding of regulations.
1.Kazi, S. (2014). A Review Article on Nano diamonds Discussing Their Properties and Applications. International Journal of Pharmaceutical Science Invention, 3(7), 40-45. ISSN: 2319 – 6718
2.Kazi, S. (2014). Use of Traditional Plants in Diabetes Mellitus: A REVIEW. International Journal of Pharmacy, 4(4), 283-289.ISSN 2249-1848