REMOTE - Regulatory Project Manager (Part-time) Job at Platinum Resource Group, Washington DC

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  • Platinum Resource Group
  • Washington DC

Job Description

REMOTE Regulatory Project Manager



Part-time - 15 hrs / week



Location; Remote, US



JOB DESCRIPTION



We are looking for an experienced Regulatory Project Manager to support the execution of regulatory strategies within the Global Regulatory Affairs function with specific focus on regulatory filing activities, project management tools, and communication. Our client will look to you to translate global regulatory strategies into meaningful, executable submission plans, applying your project management expertise to assist in driving their pipeline of rare disease programs into the hands of patients. You'll be working on an exciting portfolio across broad therapeutic areas and modalities in both early and late-stage development programs as well as marketed products, with plenty of opportunities to broaden your experience and advance your career.



  • Partner with Regulatory leads to manage regulatory filing sub teams and sub team operations, including the coordination, prioritization, and tracking of regulatory activities associated with development and post-marketing activities.


  • Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies.


  • Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays.


  • Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines.


  • Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the portfolio to most effectively support global regulatory pathways.


  • Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are fully informed and knowledgeable of activities, progress / delays, and risks / issues.


  • Facilitate regulatory filing team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required).


  • Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices.



QUALIFICATIONS



  • Bachelor's or higher degree in a related field with >3-4 years of experience in regulatory project management, (bio)pharmaceutical project management, and/or related discipline.


  • Working knowledge of global regulatory agency regulations, guidelines, and submissions and nonclinical, clinical, and CMC (bio)pharmaceutical drug / product development.


  • Direct hands-on experience managing original Marketing Applications and/or LCM submissions from creation to submission through approval / post-approval.


  • Exceptional project management and organizational skills are required, with demonstrated ability to prioritize and manage multiple tasks and projects to achieve program and department goals under tight timelines in a cross-functional environment that values both speed and quality.


  • Demonstrated capacity for strategic thinking with a focus on regulatory strategy execution and global process improvement and optimization and passion for Client project management tool building.


  • Highly proficient with using Smartsheet, Microsoft Project, or other project scheduling tool(s) in conjunction with best practices for project scheduling techniques such as managing WBS, timelines, and critical path; direct experience with OnePager and Veeva Vault RIM is a plus.



Platinum Resource Group is a professional level consulting firm, providing resources to Fortune 1000 client companies in the areas of technology, human resources, accounting, finance, business systems and supply chain, on a contract and interim basis. PRG has operations in Orange County, San Diego, Los Angeles, and San Francisco. As a W-2 employer we offer our consultants direct deposit bi-weekly payroll, health, dental, vision benefits, paid holidays, and referral bonuses.

Job Tags

Remote job, Holiday work, Contract work, Interim role,

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