Saket Kanakdhar

+1-617-***-**** Email LinkedIn

SUMMARY As a seasoned professional with 4 years of experience in pharmacovigilance and corporate settings, I recently completed a 6-months Quality Operations Efficiency internship at Genentech. I worked for QA, gap analysis, and validation, with a strong focus on ensuring compliance with FDA regulations. I am now seeking a role as a Regulatory Affairs Associate in the biotechnology and medical device industries where I can leverage my skills to contribute to the growth of the organization. EDUCATION NORTHEASTERN UNIVERSITY, Boston, MA (GPA- 3.69/4.0) Sep 2021 – Jul 2023 Masters in Regulatory Affairs for Drugs, Biologic and Medical Devices Relevant Courses: Risk and Quality Management, Human Experimentation, Regulatory Strategy for Product Development & Lifecycle Management, FDA Medical Device Regulation, Legal Issues in Regulation, Medical Device Development, Safety Sciences, Project Management for regulatory affairs, of Global regulatory Affairs Practical application, Cybersecurity and Regulation of Digital Health Technologies, Product Development and Process Validation. PUNE UNIVERSITY, Pune, INDIA (GPA- 3.5/4.0) Jul 2012 - Jun 2016 Bachelor of Pharmacy

Relevant Courses: Pharmaceutical Jurisprudence, Biopharmaceutics, Clinical Pharmacy, Pharmacology, Biotechnology, Quality Assurance, Industrial & Pharmaceutical Engineering, Medicinal Chemistry, Bio-Organic Chemistry & Drug Development. EXPERIENCE Quality Operations Efficiency Intern

Genentech, Hillsboro, Oregon Sep 2022 – Mar 2023

• Supported quality-related initiatives, including root cause analysis, gap analysis, and corrective action plans. Utilized EVALRoche for document review and approval tasks in process validation.

• Streamlined workflows for the QA&V, QC team at Genentech by creating a Trello board, resulting in improved efficiency.

• Collaborated with cross-functional teams, including quality control, to ensure all documentation met required standards and expectations. Developed multiple Standard Operating Procedures (SOPs) binders in Veeva Vault to accurately organize documents.

• Designed and developed a comprehensive G-Site for the Quality Assurance Parental Launch and New Technology (PLANT) and Quality Validation team at Genentech, providing key information on the team's structure, goals, and workflows. Participated in weekly huddle meetings and discussions on project updates, task assignments, and process improvements.

Clinical Safety Specialist

TATA Consultancy Services (TCS), Thane, India Apr 2018 - Jul 2021

• Performed accurate coding of incoming adverse events and other case information using MedRA terminology. Led as a case processor for 15-20 cases per day, promptly and accurately identifying, interpreting, and extracting adverse events and case information from various source documents.

• Carried out Corrective and Preventative actions on priority for device-related adverse events captured incorrectly for up to 3-5 cases. Ensured medical plausibility, consistency, and completeness of ADR case reports, and ensured case-level status complied with regulatory agency reporting requirements.

• Modified amendments in case corrections and marked them significant or non-significant as per the scenario utilizing ARGUS.

• Identified and processed Product Technical Complaints in more than 100 source documents requiring further action by local affiliates, ensuring timely and accurate reporting.

Unblinding and SUSAR officer

TATA Consultancy Services (TCS), Thane, India

• Attended safe track and unblinding calls as a part of emergency unblinding team and transferred information extracted in the call and cross verify with the follow-up e-mail and then composing a reply with the information and data needed and sending across from the company’s authorized Email-Id.

• Acquired demographic information along with patient ID and other related information about patient from the team members, and access the medical case study and records of the patient from the various tools designed specifically for this project, decode and extract information about medical history and the on-going medical treatment of the subject under the study.

Marketing Executive

GLAXO-SMITH KLEIN, Pune, India Jul 2017 - Mar 2018

• Conducted thorough market research to produce insightful market surveillance reports, enabling the team to identify new growth opportunities.

• Collaborated closely with senior marketing executives to gather sales data, which was compiled and presented to inform strategic decision-making.

• Demonstrated strong leadership and communication skills by training and mentoring new marketing executive recruits during handover-takeover (HOTO) processes, resulting in a smooth transition and a high level of team cohesion Assistant Laboratory Practitioner Intern

SERUM PVT LTD, Pune, India May 2015-Jun 2015

• Contributed to the implementation of laboratory safety and quality control procedures, ensuring compliance with industry standards and regulations.

• Drafted Standard Operating Procedures (SOPs) for extraction, purification, manufacturing, and packaging of raw material for vaccines.

• Maintained laboratory equipment and instruments, including calibration and maintenance activities, to ensure accurate and reliable test results. SKILLS Regulatory: FDA and EU MDR Regulations, ICH and ISO guidelines, Regulatory Operations Process, Regulatory Submissions (510K, PMA, HDE, HUD, CMC, IND, NDA, ANDA), CMDR Regulations, Quality Control and Validation Process, Clinical Quality Management, CE marking, GxP, Design Control, Pharmacovigilance, eCTD, De Novo, Corrective and Preventative actions (CAPA), Regulatory Writing, Medical device safety, Clinical Trial Protocol, Investigator's Brochure, Informed Consent Form, IRB, Document Control, Change Management, IRB, Clinical Data Analysis and Review, SUSAR. Technical: Obtained skillset for Safety Database Application: Working experience on ARGUS safety database (including Argus 8.1.2 updated version 8.1), Cara Search Engine, MeDRA Browser, Microsoft (Word, Excel, Outlook, PowerPoint, Teams), Adobe Acrobat, SharePoint, EVALRoche, Veeva Vault, Gantt Chart. Core Competencies: Regulatory Intelligence, Data Integrity Compliance, Project Planning and Management, Pro-active in problem solving ACADEMIC PROJECTS

• Developed product strategy for a digital continuous glucose monitor, defining the process development for software and cybersecurity regulatory standpoint.

• Created a 21 CFR 50 compliant informed consent form using ClinicalTrials.gov, to ensure moral and legal compliance for the Phase II OTX-CSI drug trial.

• Evaluated potential comparison between virtual clinical trial versus centralized clinical trials for a startup company's medical product, considering SWOT analysis, cost analysis, market demand, and FDA requirements for virtual clinical trial data.

• Designed a 21 CFR 50 compliant Informed Consent Form for Phase II trial of OTX-CSI drug utilizing ClinicalTrials.gov.

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