Mag. Shakul Hameed

• Responsible for E2E Regulatory data/information management • Accountable for the implementation and management of a comprehensive data model, master data and electronic standards. • Provide oversight for ongoing information management of submission records, system changes and associated global product registration records. • Lead initiatives to integrate Regulatory information and records globally and for acquired assets and products

Offering consultation and subject matter expertise in Regulatory Submissions, Standards, Process and Management, Global Regulatory requirements, IT and Regulatory Affairs Strategy for EDMS and eCTD publishing, Submission Publishing - Paper, eCTD, NEES. xEVMPD, SPOR/IDMP Readiness, Labelling Management (SPL, SPM, ePI), Regulatory Registration tracking and Data Management, System Validation, Regulatory Operations business process optimization and digitalization.

• Represents the business needs related to technology, systems & Regulatory Information Management (RIM) • Drives the maintenance & implementation of regulatory systems and tools • Drives business support & standards for Global Regulatory Affairs in partnership with R&D IT. • Establishes, updates, implements & provides guidance on Regulatory-required formats, templates, policies, standards, Intelligence & procedures where technology & information management are impacted.

• Manage and Lead Submission projects, Publishing and RA Operation special projects in a cross-functional, cross-geographical department. • Interact with business partners and health authorities • Partner with key line functions and groups on the creation of new submission processes and implementation procedures • Key contact for RA Operation systems and Processes advice, questions or improvements • Create, review, and maintain RA Operations related process documents.

• Provide submission related regulatory advice to different project teams and other key stakeholders • Key contact for submission related standards and strategy advice, questions and improvements • Interact with business partners and Health Authorities (HA’s) • Assist to develop and implement submission strategies (Operation)

• Effectively coordinate with Submission managers, Cross functional line function to prepare high quality and technically valid Paper, eCTD and Nee’S format. • Training or conducting awareness sessions related to Regulatory Submission (Operations) Publishing process to global colleagues. • Actively involved and contributed in Regulatory Document Preparation (Business Guidance, SOP’s & Process Maps), Submission Publishing, Submission Template and Testing.

Understand and Interprets US FDA, EMEA, TGA and Health Canada Regulatory Requirements; Responsible for the coordination and preparation of various Electronic Submissions for US FDA (eCTD Submissions) like NDA, IND, ANDA, DMF and SPL/PLR. For EMEA different types of eCTD submission Procedures like Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP) and Active Substance Master File (ASMF).

Preparation of Regulatory Documents in Health Authority required formats (Paper and PDF Copies) and compile the dossiers according to the specific requirements for Europe and other non-regulated & semi regulated Countries. Making product & Packing material specifications in pdf format and maintenance of the regulatory documents including the labeling documents

EU Regulatory Affaris