Regulatory Affairs Intern

Anisha Devi Marni

*****.*@************.*** +1-617-***-**** www.linkedin.com/in/anisha-marni-799675204 EDUCATION

Northeastern University Boston, MA

Master of Science in Regulatory Affairs of Drugs, Medical Devices, and Biologicals – 3.88 GPA Jan 2021-Apr 2023

• Relevant Coursework: Regulatory Strategy of Product Development, Global Impact of eCTD Submission, Human Experimentation, Therapeutic Product Development, Regulatory Compliance and Practice, Introduction to FDA Pharma Regulation, Advertising and Promotional labelling, Pharma and Medical Device Law Jawaharlal Nehru Technology University AP, India

Bachelor of Science in Pharmacy Jun 2016- Sept 2020

• Relevant Coursework: Industrial Pharmacy, Medicinal Chemistry, Pharmacology, Medicinal Chemistry, Human Anatomy and Physiology, Pharmaceutical Jurisprudence, Pharmacognosy WORK EXPERIENCE

LifeStory Health Boston, MA

Capstone Project Intern Jan 2023-Apr2023

• Conducted research and developed clinical trial design for ovarian cancer screening program including providing inclusion/exclusion criteria, statistical analysis plan, and IRB submission

• Generated Clinical Trial Protocol and related documents, such as informed consent forms and study reports

• Provided input on study recruitment strategies to ensure successful study implementation Ultragenyx Pharmaceuticals Woburn, MA

Regulatory Affairs and Quality Control Co-op Jan 2022-July 2022 Regulatory Affairs Responsibilities:

• Regulatory correspondence and reporting spreadsheet was maintained and tracked

• Worked on updating CMC sections of IND, IMPD documents, CTAs, and Briefing book

• Quality checking the published output of documents in terms of hyperlinks, bookmarks, thumbnails, etc.,

• Familiarity with the Content Verification forms and its process

• Experienced on Veeva RIM, Liquent Access, and Please Review Quality Control responsibilities:

• Performed Quality testing of AAV based Gene Therapy GMP Samples, Processed, and Reviewed data

• Hands on experience of UV-Visible Spectrophotometry, HPLC-SEC, and CE-SDS

• Authored and Reviewed Standard Operating Procedures (SOP), & Test Method Protocols, and Executed Validation Runs

• Supported the lab in terms of Reagents and Chemicals maintenance, Logbook review, 5S implementation, and shipping out samples

• Familiarized in Supplier Qualification, managing deviations, CAPA, and Change controls with Veeva Vault Electronic Data Management System (EDMS)

• Experienced on Veeva Quality, LIMS, Arxspan, and Oracle Procurement Laurus Labs Limited Vizag, India

Regulatory Affairs and Quality Intern Sept 2019-Oct 2019

• Collaborated with the team in Quality Assurance, maintained GxP documents and audited product development

• Assisted in development of dossiers & regulatory submissions for a drug product as per FDA regulations

• Coordinated within a team for initiation of a Corrective and Preventive Action (CAPA) for root cause analysis ACADEMIC PROJECTS

• Compiled a strategic document on how to submit IND electronically in eCTD format in compliance with 21 CFR Part 312 and Multidisciplinary ICH Guidelines

• Drafted a report which involves coordinating and managing IRB approved clinical trials from start to finish, including protocol development, subject recruitment, data collection, and analysis

• Submitted a comprehensive essay on clinical studies by Genentech Pharmaceuticals for Cobimetinib prior to FDA review and marketing approval using a valuable resource, clinicaltrials.gov database required for a regulatory professional

• Paged a report outlining recommendations for preparation, submission, and maintenance of New Drug Application (NDA) by referencing applicable regulations from 21 CFR 314 and advice from FDA Guidance’s and ICH Guidelines SKILLS

• Technical: IND, IMPD, CTA, BLA, NDA, ANDA, eCTD, ICH, Clinical trials, Change controls, Deviations, CAPA, Analytical Methods, SOP’s, cGMP

• Functional: MS Word, Excel, PowerPoint, SharePoint, Outlook, Teams, Adobe

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