Regulatory Project Manager
 Advanced Clinical | |
 United States, California, Foster City | |
 Jan 22, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Regulatory Project Manager in Foster City, CA. The Regulatory Project Manager role will be responsible for supporting project communications, conducting follow-up with project team members, partners or stakeholders, tracking project information, helping maintain project timelines, and performing other administrative work to support RPM colleagues and project team members. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES * Manages basic department/cross-functional specific programs and/or initiatives. * Manages basic project/initiative communications and works in partnership with senior-level Project Management to ensure that all stakeholders are fully informed and knowledgeable of project activities and their status. * Provides Regulatory Project Management support for assigned programs/projects/initiatives; may attend sub-team meetings. * Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate. * Identifies and manages critical path activities. * Supports 1 - 2 Regulatory Projects, including but not limited to cross-reference INDs, original INDs, and simpler RTQs. * In relation to regulatory submissions, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources. * Works in partnership with senior-level Project Management and/or Project Lead to ensure timely, efficient and effective meetings and progress on activities between meetings. * Works in partnership with senior Project Manager and/or Project Lead to execute on deliverables. * May coordinates basic team operations and communications. * Works with senior Project Management to generate periodic project team and sub-team updates and assists with preparation of formal presentations as required. * May implement routine process improvement and optimization initiatives as required. * May manage sub-projects as assigned. * Focuses on operational tasks, learns how to manage submissions independently, and starts to develop a strategic mindset. * Ensures project work complies with established practices, policies and processes and any regulatory or other requirements EXPERIENCE & EDUCATION * BA/ BS with 5+ years relevant project management or scientific experience in the biopharma industry, or 3+ years relevant experience with an advanced degree. * A scientific background is preferred. * Relevant experience consists of work in a scientific field or equivalent experience with R&D project teams and/or cross-functional project management activities. * PMP (Project Management Professional) or other PM certification or equivalent is a plus. To be a best-fit your strengths must include: * Knowledge of the drug development process. * Modest knowledge of regulatory requirements specific to key regions such as the US and EU, and have a general awareness of current global and regional trends in Regulatory Affairs. * Experience in assisting with multiple projects and flexibly adapting to changing priorities. * Experience in assisting with project scope, timelines and deliverables. * Awareness of Agile Methodologies and their application in the R&D biopharma environment. * Organizational awareness and knowledge of change management with the ability to support senior Project Management in an evolving environment. * Ability to communicate in a clear and concise manner. * Ability to support team-oriented, highly-matrixed environment. * Ability to execute multiple tasks as assigned. * Must be quality driven individual with strong attention to detail and accuracy. * Ability to support an inclusive environment of empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration. * Knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |