Accountable for the production and dispatch of regulatory submissions that support the development, registration, and marketing of products for Accenture’s clients. Ensuring that the electronic submission output complies with regional and country specific regulatory requirements as well as internal quality standards. Make decisions when they must be made taking into account the cost and benefits of decisions. Manage publishing activities at the regional level ensuring delivery on key regulatory submission milestones and maintains compliance with applicable regulatory obligations. Responsible for ensuring successful portfolio delivery to designated health authorities to agreed time and quality standards. Managing the resources associated with compilation, publishing and delivery of all sponsor applications that support new development projects and maintain regulatory compliance for investigational new drug applications and existing marketed product applications.Planning, tracking, resource allocation, and project management of regulatory publishing activitieseCTD tracking, compilation, and submission of US/EU/CH/CA/GCC/AU/NZ/TH/ZA submissions with continuing lifecycle maintenance. Lifecycle management of investigational and marketing applications across multiple regions. Submission dispatch to Health AuthorityProcess reviews, working guide development and maintenance. Training & Development for on-site and offshore resources to foster growth in team members and peers.

Oversees the management of numerous regulatory submission projects ensuring submissions are in compliance with global regulatory requirements and meet Submission timelines. As a Sr. Project coordinator responsible for original applications, life-cycle submissions, this includes annual reports, CMC supplements, labeling supplements, Advertising/Promotional Labeling submissions and other amendments to regions including the US, Canada, EMA and other regions. Responsible for overall quality of submissions, works closely with cross-functional groups in developing optimal timelines to support filings and approvals of major dossiers (IND, NDA, BLA, ANDA, MAA, CTA) in eCTD, NEES, and paper formats. Project Coordinator for internal and external deliverables managing team members and projects including SPL, document formatting, original applications and maintenance submissions. Ensures that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, Specific Project Specifications, and Policies throughout the lifecycle of the submission.Oversees automation projects in regulatory environment. Submitted 50+ ideas in various areas of Regulatory publishing. Successfully completed 2 big automation projects in regulatory which resulted in 65% reduction time with 100% quality. As a team lead conducts performance reviews of publishing team and is responsible for ensuring all team members are trained as needed. Serving as career counselor to team members and help team members set personal and career objectives. Represents team members in annual review process. Leading a team of publishers who support a major, international pharmaceutical company to augment their existing staff, working directly with their staff daily using the outside company's tools, software, and standards for multiple lines of business working in word and PDF, eCTD, CTA, and Nees

Coordinated multiple eCTD submissions including INDs, NDAs, ANDAs, and MAAs including original applications and maintenance submissions from project kick-off through submission to the agency.Prepares submissions for FDA drug approvals as well as various coordinates several projects, specializes in maintenance submissions, compliant with SOPs. Also responsible for Image QA, Transformation/Concatenation, Bookmarking, Hyperlinking, Issue Identification, Initial RO Reviews, Use of MS Office programs, Use of Internal and External Publishing Tools, Completion of assigned tasks with a high degree of quality in a timely manner. Expertise in Datasets (SDTM, ADAM, SEND) publishing. As an active member of the Regulatory Operations Automation team submitted various ideas for automation. Most of the automation concepts resulted in reducing timelines and improved quality. As an active member of the Regulatory Operations Training Initiative Committee helped to plan, present, and implement training throughout the department.

Responsibilities consisted of coordinating multiple eCTD submissions, knowledge of the drug development life cycle, organization of folders/files needed to build electronic submissions, submission through the FDA Electronic Submission Gateway and creation of electronic media for client or submission deliverables. Executed document coordinator tasks while identifying and resolving both content issues for the client as well as internal publishing issues to assure Document Level QA. Tasks included bookmarking, hyperlinking, transformation/concatenation, image QA and other tasks necessary for electronic submission of regulatory documentation to the FDA or other regulatory agencies. Participated in the development of internal projects, client teleconferences, creating and delivering presentations for departmental sustainment training and new hire trainings.