Ramya Sudula

• Change assessments including labeling, design, and manufacturing for devices and combination products • Led effective pre-submission meetings with Health Canada, negotiating with Health Canada and HQ on developing a pragmatic clinical strategy for a critical device needed to strengthen the VI portfolio as well as aligning the drug testing requirements with the FDA DES guidance • Prepared high-quality Class II- IV new MDL applications and amendments (CRM & VI devices including complex combination products) with minimal screening deficiencies and timely responses to Request for Additional Information (30+ successful market authorizations) • Established long-term launch strategy for SaMD applications aligning with customer needs and feedback • Complaint management and timely reporting of MDPRs, FRNs, ASRs, and Sec. 36 conditional license requirements • Promptly initiated recall processes effectively closing out all activities with appropriate effectiveness checks in compliance with GUI-0054 • Active role in MedTech Canada’s sub-committees (served a term as a co-chair for the Pre-market Licensing sub-committee in 2019, a member of Post-market Vigilance sub-committee & Environmental sub-committee as well as various working groups such as PRCI); conveying policy and guideline changes, performing gap assessments to assist in the alignment of HQ operations with the evolving requirements of Health Canada • Compiled required documentation and timely submission of Special Access Program requests, MDEL and Annual License Renewals as Health Canada’s Regulatory Correspondent and MDEL Senior Official • Successfully led 2 Health Canada Regulatory MDEL Inspections (0 deficiencies, 0 observations, Compliant rating) • Established a robust QMS, building SOPs, WIs, QMS Manual, and Quality Policies, maintaining an effective CAPA management system • Successfully led ISO 13485:2016 audits as an Internal Auditor (0 major findings)

• Managing timely Mandatory Problem Reporting to Health Canada • Developing quality Medical Device License Submissions to Health Canada for market authorization • Managing clinical trials • Assessing RFPs’ objectives and developing proposal submissions to meet individual needs of buying groups and Health centers through cross-functional collaboration • Ensuring tender compliance by tracking and monitoring the alignment of sales against contractual agreements

Working within the Medical Education team • Developing the Medical Education plan, including the review process of grant requests against pre-determined approval criteria • Coordinating review of medical education requests and liaise with external applicants to guide them through the application process • Liaise with Medical Education team and cross functional partners in the assessment of requests • Developing tools, including templates, process maps, a website and guidance documents to support the review process of medical education requests • Negotiating with external HCPs and internal GSK cross-functional partners on funding decisions • Establishing a Rolling Budget for medical education spend; strategically allocating budget based on historical trend analysis

• Provided scientific support by conducting literature searches for clinical data and developing Efficacy and Safety Summary documents, assisting in strategizing the positioning of reimbursement submission packages that align with pCODR and CDR requirements • Conducted and facilitated training sessions for Medical Science Liaisons and Medical Sales Representatives • Managed publication requirements for a clinical study, negotiating with an external medical writer; governing the process for compliance with GSK Canada policies • Collaborated with the cross-functional Medical Education Workstream team in developing tools, guidance documents, and Areas of Medical Education Interest for a new business function • Managed Investigator Sponsored Studies by maintaining databases, critically analyzing protocols, liaising with Scientific Advisors to address study protocol queries, and collecting quarterly study metrics

• Investigated the enzyme kinetics of Mycobacterium tuberculosis Folypolyglutamate synthase • Acquired laboratory techniques including enzyme activity assays and SDS-gel electrophoresis • Analyzed data and performed statistical analysis • Adopted independent research skills in a time constrained environment with minimal resources or supervision • Presented results to the Biology faculty

• Organized and facilitated study groups for students • Planned study sessions that catered to individual needs