Harsh Shah

[A] Project Management: (October 2022 Onwards) To coordinate internal and external resources, ensuring projects remain within scope, schedule, and defined budgets, in collaboration with project staff from various functional departments To establish and maintain processes to manage scope over the project lifecycle, setting project quality and performance standards, and assessing and managing risk within, and across, multiple projects. Project initiation-Regulatory Submission-Launch. Project planning, scheduling and implementation. Report project outcomes and/or risks to the appropriate management channels as needed—escalating issues as necessary based on project work plans. End to end responsibility of managing the product development program. Flawless support in execution of scale-up and technology transfer from lab to commercial scale. Preparation and managing yearly budgets of all projects as well as facility. Provide budget vs. actual variance reports in monthly updates. [B] Business Development: To ask quotation as well as document requirement for tender submission from USFDA approved organization for USFDA approved products in Saudi Arab, Bahrain, Sri Lanka. To submit the quotation with requested documents for tender submission to the agent in Saudi Arab, Bahrain, Sri Lanka. Extension of USFDA approved products to other regulatory authorities (i.e. Chile) with fulfilment of regulatory requirement. [C] ANDA: US-FDA Submission: (April 2021 – October 2022) Compilation & ANDAs (Including FTF & All type of solid oral projects Tablets & Capsules) Reviewing Technology Transfer document e-CTD submission of ANDAs Compilation & Review of ANDAs Database Management of various declarations used in ANDA submissions. Communication with Cross Functional Teams (CFTs) for timely submissions of ANDAs Review of Summary Basis of Approvals available on USFDA website. Review of ANDA modules to ensure Quality submission of ANDAs.

[A] ANDA: US-FDA Submission: Compilation & ANDAs (Including FTF & All type of solid oral projects Tablets & Capsules) Reviewing Technology Transfer document e-CTD submission of ANDAs Compilation & Review of ANDAs Database Management of various declarations used in ANDA submissions. Communication with Cross Functional Teams (CFTs) for timely submissions of ANDAs Review of Summary Basis of Approvals available on USFDA website. Review of ANDA documents (i.e. specifications, bill of materials, Product Development Reports etc.) received from CFTs Review of ANDA modules to ensure Quality submission of ANDAs.

[A] ANDA: US-FDA Submission: Handling of Post-ANDA Submission activities: Evaluation of Post-Approval Changes & submission of Amendment of appropriate category [Annual Report, CBE-0, CBE-30 & PAS] with required documentation filing. Reviewing Technology Transfer document e-CTD submission Compilation & Review of ANDAs

[A] BRAZIL: ANVISA dossier submissions (6 Months) Compilation of dossiers (All type of solid oral dosage forms tablets and capsules) Post dossier submissions (i.e. Renewal registrations)

[A] ANDA: US-FDA Submission: Compilation & Review of ANDAs (Including FTF & All type of solid oral Projects Tablets & Capsules) Handling of Post-ANDA Submission activities: Timely submission of CMC and BE-Dissolution Deficiency Response Evaluation of Post-Approval Changes & submission of Amendment of appropriate category [Annual Report, CBE-0, CBE-30 & PAS] with required documentation filing Reviewing Technology Transfer document e-CTD submission [B] ANDS: CANADA Submission: Compilation & Review of ANDS Handling of Post-ANDS Submission activities: Timely submission of Deficiency Response Evaluation of Post-Approval Changes & submission of Amendment of appropriate category with required documentation filing Reviewing Technology Transfer document [C] Drug Master File (DMF) – GLOBAL (US, Europe & ROW): Compilation & Review of Global DMF (EUDMF, USDMF etc.) for Regulated Markets Handling of Post-DMF Submission activities: Deficiency Response Handling for Global DMFs across the globe Evaluation of changes & submission of Amendment with appropriate documentation filing Overall Responsible for Review & Tracking of Out-sourced DMFs: Co-ordination with the 3rd party / vendor for the pending & on-going DMF relevant matter [D] Development to Commercial in US Market Clearance of Critical Development Checklists (i.e. IIG, Proportional Similarity, Trade Dress, Dissolution, Iron Content) Review, Design & Approval of API, In-Process, Intermediate & Finished Product Specification Current awareness about GDUFA requirement of APIs & FDFs & Co-ordination with the 3rd Party to ensure with the GDUFA requirements GDUFA Requirements: DMF Fee ANDA Fee Facility Fee Self Identification Initial Completeness Assessment [E] Europe Site shift activity Review of site shift documents GAP Analysis

59.25%

53.85%

61.63%

B+ (First Class)

87.71%