Our client, a leader in the pharmaceutical industry, is seeking a Regulatory Project Manager to join their team. In this role, the Regulatory Project Manager will be responsible for supporting the execution of regulatory strategies within the Global Regulatory Affairs function with specific focus on regulatory filing activities, project management tools, and communication.
**This job is a remote position - East Coast Preferred**
**This is a part time role - up to 20hrs per week**
**W2 Only**
Responsibilities:
The Regulatory Project Manager will:
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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
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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
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Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
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Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
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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
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Facilitate regulatory filing team and working group meetings
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Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices
Qualifications:
- 3+ years of experience in Regulatory Affairs Project Management, Biopharma/Pharma Project Management and/or a related field
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Extensive experience in regulatory affairs or drug development, specifically excluding compliance-heavy backgrounds.
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Project management skills coupled with a deep understanding of regulatory affairs terminology and processes.
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Proven ability to quickly adapt and excel in a challenging environment, demonstrating readiness to hit the ground running.
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Bachelor's or higher Degree in a related field
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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
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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 novel project management tool building
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Highly proficient with using Smartsheet, Microsoft Project, or other project scheduling tool(s)
- Experience in planning and managing 100+ rows in Smartsheet or MS Project
Desired Skills:
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Direct experience with OnePager and Veeva Vault RIM