Arun Vijayakumar Email & Phone Number

Toronto, Ontario, Canada

Toronto, Canada Area

Regulatory • Authoring and Validation of Structured Product Labels (SPL) for US based pharma companies and assisted in Product Monograph (PM) labelling and knowledge in the pilot XML PM project for Canadian companies • European labeling structured authoring to create, edit, and validate labeling documents translated to their local jurisdiction while making submissions compliant to EU regulatory requirements (CP, DCP/MRP, and National Procedures)• Developed a thorough working knowledge of i4i’s authoring software (A4L) and conducted trainings/demos and provided regulatory support to internal/external clients to ensure submissions were compliant based on labeling requirements for FDA’s regulations and SPL Implementation guide with Validation.• Worked extensively with Microsoft Word to create, review and validate SPLs and Product Monographs• Expertise in FDA Establishment Licensing, Labeler Code Requests, Lot Distribution, BNCC, Bulk Ingredients, GDUFA, Human Prescription (Rx), Over-the-Counter (OTC), Medical Devices, Veterinary and Cosmetics SPLs.• Act as a liaison between clients and regulatory bodies for timely fixes for issues in order to get submissions approved.Quality Assurance• Assisted the Quality Assurance department to test new versions of i4i’s software and services• Performed test cases, documented results, reported any defects found, confirmed fixes after implementation• Carried out IQ, OQ, and PQ executions for software designed for clients and flagged documentation/validation errors to help for future testing• Reviewed converted SPLs received from clients and internal conversion team to catch discrepancies at an in-depth level• Operated a document analysis program to analyze and compare internal converted labels, fix any discrepancies (content mismatch, technical errors, etc.) and promote documents to ready for submission.

Toronto, Canada Area

Roles and Responsibilities:• Developed a working knowledge of i4i's software products and internal tracking systems• Member of the Product Conversion team, receiving submission labelling documents from internal/external customers and converting them into SPLs using i4i's A4L software• Investigated and developed industry expertise through regularly attended FDA Webinars, Tech Team Meetings and Certification trainings. Provided subject matter support to internal i4i teams• Provided regulatory support to external customers having issues with FDA Gateway validation errors, and troubleshooting A4L-related errors to clients, in order to provide ready-to-submit, compliant submission documents.• Contributed to project success in a team environment while simultaneously completing individual tasks by meeting weekly submission deadlines/goals for primary pharmaceutical client, to fulfill long-term contract goal• Reviewed, analyzed, and documented internal conversion team outgoing documents to clients, in order to ensure highest degree of accuracy and compliance.• Assisted the Quality Control team to test either new versions of i4i software prior to general release or fixes to defects in current releases

Toronto, Canada Area

• Created detailed, lesson plans that were curated to individual learning styles with deadlines marked long-term planning of student examination preparation, identified strengths/weaknesses, kept motivation and morale high.• Positively communicated with parents and students regarding progress, encouraging hard-work• Fit communication style to needs of different students, dependent on age, culture, ability and learning style

Toronto, Canada Area

• Performed comparative product testing along with the analysis of batch records and stability data• Responsible for screening quality control protocols, keeping equipment and facility clean and up to sanitary standards, ordering and shipping of equipment• Utilized scientific databases and literature reviews to cross-reference results and check for compliance• Corresponded findings with colleagues and organized group meetings to interpret results, discussed risk-mitigation strategies, and ensured timeframe of goals were met• Delegated responsibilities to staff and volunteers, and managed/scheduled appointments with Regulators • Utilized critical thinking strategies to manage project goals, while encouraging teamwork and productivity

Post Graduate Certificate In Regulatory Affairs (Rapc)

Bachelor Of Science - Hbsc - Life Sciences - Human Biology And Toxicology Major