Job description

The Regulatory Project Manager (PM) will work in close collaboration with Regulatory Strategy and Operational teams, as well as cross-functional teams across the organization (i.e., Clinical, Nonclinical, and Quality) to build and manage timelines to support regulatory filings through licensure and beyond.

Heres What Youll Do:

• Define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams, including INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests, etc.
• Develop submission project timelines that identify key milestones to meet business objectives (e.g. from clinical trial initiation to regulatory submission and approval)
• Track and monitor timelines for key activities (e.g. database lock, document deliverables, authoring responses to health authority questions and meeting regulatory commitments).
• Ensure roles and responsibilities for project team members are clearly documented.
• Lead submission working group cross functional meetings to drive decision making and project execution.
• Ensure creation of agendas, meeting minutes, and tracking/resolution of action items.
• Proactively provide status updates to designated stakeholders via dashboards and milestone reports, and ensure leadership is aware of critical considerations.
• Ensure overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions.
• Identify and recommend solutions for timeline concerns or obstacles, including risks and issues; engaging appropriate leads for mitigation and resolution, ensuring that all issues arrive at a conclusion or recommendation.
• May assist in management of special projects as needed, e.g. oversight of system/process improvement projects.

Heres What Youll Bring to the Table:

• BS degree in a scientific field with 8 years of experience in a biotechnology or pharmaceutical setting
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General knowledge of drug development
• Proven track record of successful project management experience supporting early- and late-stage and submission programs
• Leadership skills, including experience leading multi-disciplinary project teams
• Strong project management skills
• Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally
• Strong personal and leadership skills to influence without authority, motivate others and manage conflict
• Strong communicator and team player
• Strong working knowledge of MS Project, Smartsheet and timeline visualization software (i.e. One Pager, ThinkCell, etc.)
• Preferred: Project/program management training

PRECISION LIFE SCIENCES

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