Miral Sadadiwala

Biologics and small molecule clinical, registration and post- approval CMC in global markets: IND, CTA, FDA meetings, NDA, BLA, MAA and tech transfer projects

Global RegCMC product lead for BioMarin's lead biologics commercial Enzyme Replacement Therapies (Vimizim and Aldurazyme); Global role with responsibility for ~ 70+ markets and expanding Global RegCMC lead for a monoclonal antibody developmental program Global RegCMC lead for a small molecule program (Kuvan) As a Regulatory CMC Product Lead, responsible for leading submission leads and CMC project team in preparation of strategies, submissions, and health agency responses. Represent regulatory at CMC project team (including QA, supply, and MSAT) in identification of risks and developing appropriate regulatory CMC strategies for mitigation Current projects include combination of pre-BLA and post approval life cycle management: - Key post-approval projects include analytical transfers, new purity method development, new raw materials for purity tests, DS/DP manufacturing transfers (Tech Transfers), Scale-up, PACMPs, Multiple major and moderate In-process changes to upstream and downstream steps, ICH Q12 compliance etc. - Original registrations for global expansion - Post-market commitments - Type B - PreIND FDA meeting and IND preparation - Type C FDA meeting

Prepare regulatory CMC strategies and manage submission preparation for clinical phase and marketed Biologics-Device and Vaccines-Device combination products; Agency interactions - US Type C meetings & EU scientific advice packages. SME for global regulatory requirements for single integral, co-packaged and cross-labeled combination products. Key highlights: Clinical to commercial CMC bridging strategies, US FDA 21 CFR 4, EU EMA/MDR, Notified Body Opinion, Article 117 substantial change assessment, human factors strategy, and evolving combination product regulations worldwide. Submissions - INDs, CTAs, BLAs, MAAs, Post-approval supplements/variations, PACMPs, Human Factors submissions, NBOp, Ancillary Device Dossiers, DS/DP site transfers (tech transfers and scale up)

Regulatory CMC lead for Mylan's key specialty products - EpiPen Auto-injector Aseptically manufactured Sterile Injectables such as Autoinjectors, Prefilled Syringes and Vials. External CMO manufactured products New registration applications, Post-Approval CMC supplements: CBEs, PAS, ARs and general correspondences. DS/DP site transfers (tech transfers and scale up), Manufacturing process and container closure changes

New Product Development Projects: Drug/Device Combination Products- NDAs, INDs, 510K, IND annual reports, CMC amendment, human factors, type C & B briefing documents preparation and technical writing

Module 3 Remediation: • Part of CMC Remediation team which is responsible for In-process, Release, and Shelf-Life specification change control; Evaluating global impact and regulatory strategy; Filing Supplement applications; and gap analysis • Worked on Regulatory Remediation Execution Plan for company's ANDAs/NDAs from regulatory side • Regulatory Applications: Prepared red lines of CTD sections required for supplement applications to implement changes in existing test methods and addition of new methods for the identification/assay, sterility, volume, particulate matter, pH, BETs, etc.; widening and tightening of release and shelf life specifications; change in stability test time intervals etc. • Review and evaluate gap assessment against current source guidance documents to determine its current validity as a regulatory gap • Analyze gaps associated with 32p33, 32p51, 32p52, 32p34, 32p81, 32p82, and Annual Report section 1.13.5 (CMC Index) by cross functioning with quality, manufacturing, and test method assessment team; Make appropriate changes to the M3 CTD sections as per the test method assessment results • Test Method Remediation Project: Processed changes in 245 HPLC methods via Annual Reports; Created 32p52 and 32s42 for new and updated methods as a part of test method suitability initiative program • Work cross functionally with Microbiology/Chemistry team and third party validation consultants regarding assessment of in house stability test methods; Evaluate compendial/Non-compendial status and execute regulatory filing necessary to implement change; Create global regulatory strategy to determine global impact • Check internal methods with the current USP to determine the possibility of method to file as USP equivalent • Analyze PCRs; Determine the regions affected; Write background, description of change, and justification of the CMC change in post market regulatory strategy • Tools – ISIWriter, GDR, GPR, SAP, EnterPASS, eDocs, eCTD etc.

• Prepared regulatory submissions for new/in-line product support in the region • Supported Latin America regulatory teams for new registration and renewals of the products manufactured and approved in United States • Supported Latin America regulatory teams for new registration and renewals of the products manufactured and approved in Asia, Europe, Australia and New Zealand. • Applications: 1) Certificate to Foreign Government (CFG) 2) Certificate of pharmaceutical products (CPP) 3) Certificate of Free Sale (FSC) 4) Certificate of GMP 5) Qualitative and Quantitative Formula (QQF) and certificate 6) Outlines of manufacturing 7) Certificate of Analysis (CoA) 8) Certificate of Identical Products (CIP) 9) Letter of Authorization and Manufacturing (LoA&M) • Managed legalization, notarization and apostil • Reviewed mainly CMC sections of US, EU (MAA) and Canada (NDS) applications to create International Registration Dossier (IRD) for Latin America submissions • Prepared applications for official certificates and related documents to support regulatory processes in Canada and Latin America • Coordinated legalization processes for official certificates and related documents to support regulatory processes in Canada and Latin America • Reviewed labels and packaging components to support regulatory processes in Canada and Latin America • Coordinated translation of documents for the preparation of registration file • Participated in monthly teleconference with RA Director and RA Manager for gap analysis and to discuss the progress on various projects • Tools - Vyper, Pfizer GDMS, TrackWise, SharePoint etc.

• Assisted senior professors in Doctor of Pharmacy and Pre-Medicine department in routine lab activities and conducting Lab exams