Rohan Soneja Email & Phone Number

Chelsea, MA, US

Acton, Massachusetts, United States

Acton, Massachusetts, United States

Boston, Massachusetts, United States

• Led, and coordinated team of individuals to accomplish regulatory pathway & classification of novel device
• Performed a competitor market research and compared features of predicates with prototype device
• Conducted thorough regulatory research and analysis to determine appropriate regulatory pathway to be De Novo
• Completed comprehensive risk evaluation of identified risks, analyzed their potential implications on patient safety
• Acted as dependable point of contact for sponsor, effectively addressing queries & ensuring project updates on key milestones

Warwick, Rhode Island, United States

• Submitted regulatory roadmap & prepared regulatory strategy for 510k submission of Class II device
• Prepared a Letter to File (LTF) for supplier changes for Class II antibacterial surgical device
• Conducted thorough competitor analysis for modification of device claims to plan 510k submission
• Developed and implemented comprehensive strategies to enhance product labeling, incorporating ISO 20417:2021
• Supported activities intended to obtain and maintain FDA approval/clearance, CE marking and International submissions
• Managed compilation of essential data and initiated preparation for MSDAP geography for a portfolio of 23 medical devices

Pune, Maharashtra, India

• Collated complaint data and documented minutes for departmental QC meetings facilitating continuous process improvements
• Managed customer verbatim, medical history, and safety data of ICSRs for LATAM, USA, Health Canada, EMEA, & APAC
• Trained and mentored junior associates as SME on PV process, MedDRA coding, seriousness criteria, & PV Agreements (PVA)
• Performed ad-hoc safety surveillance activities like identifying root cause analysis, creating templates, & updating QC spreadsheets
• Reduced turnaround time & streamlined identification of drug-adverse event pairs of automation tool (IPAT) to improve efficiency
• Presented metrics of QC (quality checks), data reconciliations, CAPAs, deviations for 4 internal stakeholders (OTC, Combination,Legal, Cosmetic) while collaborating with the Functional Quality Assurance (FQA) team

Pune, Maharashtra, India

• Managed GSD mailbox for additional case creation queries, seriousness criteria resolution, and follow-up requests
• Validated accuracy and completeness of electronic ICSRs in accordance with local SOPs and regulatory requirements
• Executed case intake, triage, medical coding, case follow-up, narrative writing and submission to regulatory authorities
• Monitored medical literature reports and health authority reports accessible through EudraVigilance (EVHUMAN) platform
• Collaborated with clinical research team to configure 3 post-marketed clinical protocol request daily for system configuration
• Reported Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) with timeline of 7 to 15 calendar days to regulatory authorities like FDA, Health Canada, and EMA

Bhosari, Chinchwad

• Performed quality tests for raw materials and finished drugs utilizing assay techniques in quality control department
• Reviewed company SOPs, batch documentation, production records, & packaging records for approval from QA
• Collaborated cross functionally with QA department to maintain documentation review, quality standards & equipment logs
• Coordinated with production staff to execute current Good Manufacturing Practices cGMPs standards for tablets, capsules, and liquid dosage forms, to enhance productivity & ensure on-time batch release

Master'S Degree, Regulatory Affairs, Gpa 3.933

Relevant Coursework: Introduction to FDA pharmaceutical and medical device regulations, Human Experimentation, Regulatory Compliance.

B.Pharm, Pharmacy, 69%

Activities and Societies: Planned and executed various activities such as Induction program, sports meet and cultural events. Participated.

School, 80%

High School, H.S.C, Science, 72%