Regulatory Project Manager - Contract - Philadelphia, PA and Cambridge, MA
Play a pivotal role in bringing life-changing therapies to patients by driving regulatory projects from planning through submission.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is seeking a Regulatory Project Manager to support regulatory-focused project management activities within the rare disease and pharmaceutical space. This position requires strong organizational skills, attention to detail, and the ability to navigate complex projects in a fast-paced environment.
Primary Responsibilities:
The successful candidate will work closely with cross-functional teams to manage timelines, track progress, and ensure the successful delivery of regulatory submissions and other key initiatives.
Skills & Requirements:
- Bachelor's degree in life sciences, pharmacy, or a related field.
- Experience in project management, regulatory affairs, clinical development, or pharmaceutical operations.
- Familiarity with major regulatory submissions (e.g., INDs, CTAs, BLAs, NDAs, MAAs) and global regulatory processes.
- Knowledge of drug development, GxP, ICH guidelines, and health authority requirements is preferred.
- Strong project management, communication, and stakeholder management skills.
- Proficiency with project management tools such as Smartsheet, Microsoft Project, or similar platforms.
- Familiarity with timeline visualization tools like OnePager, think-cell, or Office Timeline is a plus.
- Advanced degree, RAC certification, or PMP certification is advantageous but not required.
The Regulatory Project Manager's responsibilities will be:
- Develop and maintain detailed project plans, timelines, and resource allocations for regulatory submissions and development milestones.
- Lead and coordinate cross-functional teams to ensure alignment and accountability for project deliverables.
- Monitor project performance, track progress against milestones, and ensure adherence to timelines and budgets.
- Identify, assess, and escalate risks, issues, and resource constraints that may impact project delivery.
- Communicate project status, risks, and next steps to internal stakeholders through clear and actionable updates.
- Prepare and present project status reports, dashboards, and updates to sponsors and management.
- Facilitate cross-functional meetings, ensuring clear agendas, decisions, and follow-ups.
- Collaborate with global and regional regulatory leads, regulatory operations, and functional contributors to support integrated submission plans and deliverables.
- Coordinate submission content deliverables, including authoring, review, approval, and readiness for publishing or dispatch.
- Support planning and follow-up for health authority interactions, including meeting preparation and response coordination.
- Drive continuous improvement in project management processes, tools, and methodologies.
- Contribute to lessons learned sessions and implement feedback to enhance future project execution.
If you are having difficulty in applying or if you have any questions, please contact Alex Kelly at a.kelly@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
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