Director, Regulatory Project Management in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Regulatory Project Management in United States.

This is a high-impact leadership opportunity for an experienced regulatory project management professional passionate about advancing innovative therapies for patients with rare diseases. In this role, you will help drive global regulatory strategies into actionable submission plans across a diverse portfolio of development-stage and marketed products. Working in a collaborative and science-driven environment, you will partner closely with regulatory leaders and cross-functional teams to ensure timely, high-quality submissions and operational excellence. The position offers strong visibility across the organization and the chance to influence regulatory processes, systems, and strategic execution on a global scale. This fully remote role is ideal for someone who thrives in fast-paced biotech settings and enjoys combining strategic thinking with hands-on execution. You’ll also have opportunities for continued professional growth while contributing to meaningful advancements in healthcare.

• Lead and coordinate regulatory filing subteams, ensuring alignment, prioritization, and execution of regulatory activities across development and post-marketing programs.
• Develop and maintain detailed regulatory project timelines using project management tools, ensuring alignment with global regulatory strategies and organizational objectives.
• Monitor submission milestones across Regulatory, Clinical, CMC, and Nonclinical functions to ensure timely execution and proactive issue resolution.
• Identify operational risks and mitigation plans while improving consistency and efficiency across regulatory programs and processes.
• Facilitate regulatory meetings, prepare agendas and documentation, track action items, and drive effective cross-functional communication.
• Build and maintain dashboards, reports, and communication tools to provide stakeholders with clear visibility into timelines, progress, risks, and milestones.
• Support the continuous improvement of regulatory business processes, project management methodologies, templates, and analytics frameworks.
• Collaborate closely with senior leadership and cross-functional teams to support strategic regulatory execution across global programs.

• Bachelor’s degree or higher in a related scientific or technical field; PMP certification is a plus.
• 8–10+ years of experience in regulatory project management, pharmaceutical/biotech project management, or related disciplines.
• Strong knowledge of global regulatory requirements, submission processes, and drug development activities across clinical, nonclinical, and CMC functions.
• Hands-on experience managing original marketing applications and lifecycle management submissions from planning through approval.
• Advanced project management and organizational skills, with the ability to manage multiple complex projects in fast-paced, cross-functional environments.
• Experience using project scheduling and management tools such as Smartsheet, Microsoft Project, One Pager, or Veeva Vault RIM.
• Strong strategic thinking and problem-solving abilities with a focus on process optimization and operational excellence.
• Excellent communication, collaboration, and meeting facilitation skills with the ability to engage stakeholders across all organizational levels.
• Ability to work independently in a remote environment while effectively managing competing priorities and tight timelines.

• Fully remote work environment with occasional travel as needed.
• Competitive salary range of $217,000 – $268,100 USD annually.
• Eligibility for annual bonus and equity incentive programs.
• Generous paid vacation and company-recognized holidays.
• Employee stock purchase plans and long-term incentive opportunities.
• Comprehensive wellbeing and wellness programs.
• Fitness reimbursement and employee wellness support.
• Tuition sponsorship and professional development opportunities.
• Inclusive, collaborative, and mission-driven company culture focused on innovation and patient impact.