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Director, Regulatory Project Manager

Company: Integrated Resources, Inc.
Location: Encinitas
Posted on: April 8, 2021

Job Description:

Director, Regulatory Project Manager in San Diego, CA at Integrated Resources, Inc Primary Location: Full time remote in the US. There may be some travel to SD in the latter half of 2021 and early 2022. Travel: 10% This position will serve as a Regulatory Project Manager on one or more of clients Program Teams, cross-functional teams responsible for implementing the companys strategy and overseeing global development activities for obeticholic acid (OCA) and our pipeline programs. CORE ACCOUNTABILITIES: The successful candidate must be able to perform each of the following satisfactorily: Drive the cross-functional decision-making process, in partnership with the global regulatory leader, for key regulatory filing milestones, by leveraging strong communication skills and experience with regulatory filing teams. Develop and coordinate a submission filing project plan for Regulatory Affairs that integrates with the Integrated Project Plans and align with corporate objectives. Manage and track the preparation of one or more marketing applications (e.g., NDA, sNDA, MAA). Actively facilitate a risks/gap analysis and work with teams and functions on mitigation plans. As appropriate, escalate issues to the GRL and cross-functional leaders for further action. Facilitate regulatory filing team meetings with the global regulatory leader, prepare minutes, identify action items. Follow up with team members as appropriate. Develop and maintain key documents such as a MS Project filing plan Ensure seamless communication within team, and between team and senior management Partner with the cross-functional colleagues to ensure timely and high-quality development of key documents, including regulatory submissions, protocols, development plans, etc. Work with finance department and cross-functional team, as needed, to track project budgets and resourcing needs and proactively flag issues; participate in annual budget and forecasts Other duties as assigned QUALIFICATIONS: Minimum of 10 years of regulatory and project management experience is required PMP or RAC certification is desirable REQUIRED KNOWLEDGE AND ABILITIES: Experience managing and tracking of US New Drug Applications (NDA), Biologics License Applications (BLA), and Investigational New Drug (IND) applications Strong verbal and written communication skills are essential. A team player with strong influencing skills and problem-solving capabilities. Strong understanding of drug development processes from strategic and operational perspectives (including regulatory understanding, clinical operations feasibility, etc.) Ability to manage and direct work in a matrix environment; ability to work collaboratively across all levels of the organization Ability to work in a fast-paced environment Excellent organization and multi-tasking skills Able to create, track and plan timelines and budgets Strong command of MS Project. Proficient in Microsoft Excel, PowerPoint & Word. Travel as required to collaborate with global teams

Keywords: Integrated Resources, Inc., Encinitas , Director, Regulatory Project Manager, Executive , Encinitas, California

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