Mariko Kobayashi

• Serving as a regulatory lead by providing expertise through the involvement with the IVD/CDx development planning.
• Adhering to Amgen's need for regulatory effort and due diligence.
• Establishing standard processes and streamlining the most efficacious regulatory path for global registration with both the internal regulatory colleagues and diagnostic partners.
• Coordinating and communicating with the diagnostic partners to align on regulatory development needs and fulfilling expectations on regulatory activities.
• Delivered IVD/CDx regulatory strategies and guidance to both Amgen's interdisciplinary teams and with the external partners to ensure successful execution of regulatory activities. E.g. Served as AMG 757 diagnostic regulatory lead since March 2021, and assisted AMG 423 diagnostic lead with regulatory planning and strategizing from December 2019 to January 2021.
• Evaluating and identifying pertinent regulations impacting both on the development of the drug and diagnostic registration.
• Coordinated with Amgen's interdisciplinary teams to prepare and conduct regulatory agency interactions in collaboration with the diagnostic partners.
• Prepared submission documents for diagnostic products, e.g. drafted SRD for AMG 199/910/890/423 (2019-2020), IDE for AMG 423 (2019 and 2020), Portugal sIDE for AMG 423 (2020), assisted with China's BD for AMG 423 (2019), AMG 423 PreSub 8, and AMG 423's RTQs (Germany and Portugal).
• Established clinical and commercial regulatory strategies that will enable successful study designs and timely registration of both therapeutic and diagnostic products. E.g. Constructed clinical and commercial strategy timelines for the submissions of both tarlatamab and DLL3 (SP347) IHC RPA.
• In collaboration with the diagnostic partners, all diagnostic regulatory activities and submissions are reviewed and approved in accordance to the therapeutic activates.
• Conducted device determination and distribution checklist from May 2019 to April 2021.
• Maintained and archived regulatory documents on EPIC, Veeva Vault RIM, BOX, and Sharepoint.
• Managed and hosted Amgen's meetings, e.g. Lunch and Learn, FastTrack, and IVD Sub-meeting.
• Maintained regional regulatory intelligence updates, e.g. JAPAC playbook updates, IVD/CDx regulatory position decks, and China IVD/CDx framework deck.
• Co-developed and maintained the IVD dashboard.
• Revised Change Control Manual to Change Control Guideline in 2020.

• Oversaw daily communication directly with 20+ vendor partners to gather technical data for formula validation.
• Monitored changing global regulations impacting the cosmetics industry.

• Ensured all product claims on components and supporting marketing vehicles were accurate and substantiated and through regulatory testing.
• Reviewed and approved product artwork and assured global compliance in collaboration with marketing partners.

• Provided support as subject matter expert in all regulatory matters for cross functional partners.
• Provided support to cross functional partners, including marketing, quality and creative teams. • Supervised Canadian, Australian, and Japanese drug registrations.

• Prepared guidance to R&D and creative teams regarding OTC labeling and claims, including working with global artwork team to maintain artwork guidelines.

• Gathered, generated and managed technical information, including formula, raw material, specification, stability data, safety and efficacy test reports, SDS, artworks, packaging materials, ingredient listings, and alcohol permits.

• Offered advice and consultation to customers and healthcare professionals regarding drug therapy, and self-care counsel; and educated patients under the supervision of a preceptor to promote appropriate patient care services.
• Supported pharmacists in delivering patient care. • Demonstrated exceptional time management, communication, and interpersonal skills.
• Provided leadership in work areas and assigned projects.
• Exercised management responsibilities through problem-solving; both as a team and independently, and as delegated by supervising pharmacist or preceptor.
• Ensured professional compliance with state and federal regulations, and daily service to internal & external customers.
• Accurately documented required manufacturing and billing information related to compounding/admixtures.

• Maintained CHO and bacterial culture, collected data for protein synthesis and titer optimization.
• Partnered with other shift personnel, and staff to carry out complex experiments for the development, characterization and validation of products and technologies in both early stage and late stage R&D research.
• Participated improving and creating of SOPs, implementation of new technologies and analytical methods, and participation in continuous improvements of the process.
• Served as a Japanese translator during the visits by Chugai (Seiyaku) Pharmaceutical Co. LTD. at the company's Oceanside location.
• Performed analysis of in-process intermediates and raw materials using HPLC, rapid bioburden and endotoxin, particle analysis, and small-scale protein purification and filtration for a variety of purposes, including investigations, process validation, process development/ improvement and routine testing.
• Contributed to process validation/characterization efforts, including but not limited to: large and small- scale studies, protocol and report preparation, validation sampling, and sample shipments.
• Contributed to advances of technological capabilities.
• Provided technical support for all associated Make-Assess-Release activities, including monitoring, trouble-shooting, corrective action and assessment and remediation of discrepant incidents impacting manufacturing materials, methods and equipment.
• Supported the implementation of manufacturing continuous improvement initiatives and support of New Product Introduction (NPI).
• Acted as Subject Matter Expert for the purposes of training S&E personnel.
• Engaged in open communication, teamwork and transparency by aligning efforts and knowledge sharing.
• Gathered data on campaign material consumption and created detailed material requirements.
• Communicates changes for site logistics and planning functions to ensure correct inputs.
• Developed proven knowledge and practical experience with core regulatory requirements.