Anushka Hemant Bhadra

Boston, MA +1-857-***-**** ad3z3t@r.postjobfree.com www.linkedin.com/in/anushkabhadra EDUCATION

Northeastern University, Boston, MA Jan 2023 - Dec 2024 Master of Science, Regulatory Affairs CGPA: 3.8

University of Mumbai, Mumbai, India Jul 2018 – Jul 2022 Bachelor of Pharmacy CGPA: 3.2

SKILLS

Technical Skills: Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams), Document Management (Adobe Acrobat, SharePoint), Pharmacovigilance Databases (MedDRA Browser, Argus, ARISg). Biopharmaceutical Regulatory: Submissions (IND, NDA, BLA, ANDA), Designations (Breakthrough, Orphan Drug), Docs (Investigator’s Brochure, eCTD)

Medical Device Regs: Quality (QMS), Submissions (510K, PMA, De Novo), Compliance (IDE, UDI, CFR 807/809, HUD, CMC) Clinical Regs: Trials (21 CFR 50, 21 CFR 56), IND (21 CFR 312.32, 21 CFR 312.310) Continuous Learning: Drug Commercialization (Coursera), Ethical Guidelines (CIOMS), Lean Six Sigma (CSSC), UX Research (Linkedin), Regulatory Compliance (RAPS)

PROFESSIONAL EXPERIENCE

IPCA Laboratories, Mumbai, India Aug 2022 – Sep 2022 Regulatory Intern

• Examined and assessed 50+ Deviations and Change Control cases, incorporating key regulatory guidelines such as ICH, Variation Guidelines, US Guidelines, and Asean Guidelines, promoting meticulous documentation practices and proficient technical writing.

• Successfully updated the Registration Status for multiple African and CIS nations, involving more than 30 drugs and biologics, enhancing comprehension of validity and renewal processes.

• Analyzed various queries received from Ministries of Health (MOHs) across 15 different countries, gaining comprehensive insights into 25 critical care and precautionary measures required for effective responses.

• Acquired proficiency in contemporary dossier submission techniques, including 10 instances of CD and eCTD submissions, and created a comprehensive flowchart for 5 Batch Manufacturing Records (BMR).

• Conducted comprehensive reviews of 20 standard documents, encompassing Certificate of Analysis (COA), Certificate of Pharmaceutical Product (COPP), Good Manufacturing Practices (GMP) Certificate, Manufacturing License, Transmissible Spongiform Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE) Reports, and Summary of Product Characteristics. Ayro Retail Solutions, Mumbai, India Jul 2021 – Aug 2021 Marketing Intern

• Managed the Marketing/Telecommunications Department, facilitating communication between 10 distributors and 50 retailers.

• Tracked feedback for a mobile application named "Retailio," designed for supply chain and medicine distribution, managing data for 100 instances on spreadsheets, thus delving into digital management techniques.

• Conducted monthly performance assessments, tracking key metrics and KPIs related to the mobile application's supply chain and distribution functions, ensuring alignment with organizational goals.

• Coordinated communication and collaboration efforts within the Marketing and Telecommunications Department, fostering efficient interactions between 10 distributors and 50 retailers on a weekly basis. PROJECTS

Constructed a Risk-Benefit Analysis framework for the weight loss medication "Belviq," enhancing understanding of safety data in accordance with FDA and EMA guidelines, analyzing adverse events and beneficial effects. Apr 2023 – Jun 2023

• Led a comprehensive review and analysis of the FDA's risk assessment framework, focusing on the critical first step of risk identification. This involved in-depth examination and scrutiny of preclinical and clinical data, as well as post-market surveillance data, to ensure a thorough understanding of potential risks associated with drugs, biologics, and medical devices.

• Collaborated on the development and implementation of risk mitigation strategies within the FDA's benefit-risk framework, focusing on seriousness, likelihood, and timely risk communication to improve product safety. Regulatory strategy for the Tandem Insulin Pump's product development and lifecycle management, with a focus on its integration into the new drug commercialization process. Jan 2023 – Apr 2023

• Implemented and contributed to the development of the Slim X2 Insulin Delivery System's Control-IQ Technology, an innovative closed-loop system that continuously optimizes insulin delivery for individuals with diabetes, effectively preventing glucose fluctuations and enhancing user experience.

• Collaborated on the integration of Basal-IQ Technology within the Slim X2 Insulin Delivery System, enhancing its predictive capabilities to anticipate and mitigate low-glucose events, thereby improving overall diabetes management and reducing the frequency and duration of hypoglycemic episodes.