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• Executed critical regulatory tasks to facilitate regulatory filing process for modified product & facilitating regulatory approvals

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• Analyzed data of adverse events (AE), serious adverse events (SAEs), and product quality complaints (PQCs), along withexpectedness, causality assessment, and reporting criteria of ICSRs within regulatory compliance• Provided active support and participation in both internal and external post-market pharmacovigilance (PV) compliance audits, effectively addressing auditors' concerns and queries

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%