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Director Head of Regulatory Operations

Company: Pharmaceuticals/Medical Supplies - Devices/Biotech
Location: San Diego
Posted on: February 15, 2018

Job Description:

Provides leadership in creating, overseeing, trouble-shooting, training, and managing electronic publications and filing processes for global regulatory submissions. Works with Regulatory Affairs and Technical Function authors as well as Regulatory Agencies to ensure that documents and submissions comply with regulatory and company guidance / specifications. Primary Responsibilities: Leadership role in the development of compliant electronic systems; plans, prepares, and tracks regulatory electronic documents and submissions ensuring conformance with regulatory requirements, guidelines, internal standards and timelines. Leads support for worldwide regulatory electronic submissions ensuring submission requirements are met. Leads in the development of processes for departmental Work Instruction Documents outlining the generation of electronic submission-ready documents. This includes providing training and technical/document support to internal disciplines and external contractors, and supporting various task force activities related to various submission types. Works with the FDA eSubs team, ESG team, and all ACADIA departments to implement and maintain processes and quality control checks, ensuring all information provided in the context of electronic submissions is accurate, complete and meets regulatory specifications. Project manager/Business Analyst for software systems projects to define requirements for, select, and implement new systems that support the Regulatory Affairs business area. End-user support - troubleshooting problems, determine configuration requirements, and system testing. System support – software lifecycle maintenance such as analyzing new releases, coordinating upgrades. System administration for account and access, user groups, maintenance, and usage reporting. Management of Regulatory validated application system software, including but not limited to, Adobe Professional, ISIToolbox, MS Office, web brousers, file transfer, eCTD validation software. Assesses the impact of eCTD-related software upgrades. Works with IT, Quality, and Regulatory Operations to ensure a smooth transition and perform training to other users as applicable. Leads in the validation process for upgrades to the electronic regulatory systems. This includes working with IT and QA to ensure the on-going validation of systems in a timely manner. Interacts with the staff regarding electronic documents and eCTD submissions, as appropriate. Performs other duties as assigned. Education/Experience/Skills: Bachelor’s degree or an equivalent combination of education and applicable job experience may be considered. A minimum of 10 years progressively responsible experience in Regulatory Operations with a focus on electronic submissions and systems. Must possess: Strong knowledge of different functional document types that comprise eCTD regulatory submissions including clinical documents and other reports. Strong knowledge in electronic content management systems. Ability to enter, analyze, and interpret metadata in eDMS. Ability to communicate clearly and concisely, both in writing & verbally, with others in a professional manner. Keep abreast and analyze of regulatory policies, procedures, security standards, GMP, and GCP. Strong knowledge and skills associated with both electronic and manual business processes. Ability to solve routine problems by following defined procedures; seeks guidance on issues outside assigned area. Ability to schedule teams work assignments independently or with moderate supervision or guidance from others. Prioritizes and organizes teams work to meet agreed upon deadlines. Ability to work efficiently in a fast-paced environment where priorities change frequently to meet the business needs. Desire to contribute as a team player who is deadline driven and works well with others. Willingness to be flexible in adjusting work hours to support the business.

Keywords: Pharmaceuticals/Medical Supplies - Devices/Biotech, San Diego, Director Head of Regulatory Operations, Executive, San Diego, California

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