Regulatory Project Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a AD, Regulatory Project Manager based in the United States.

• Translate regulatory strategy into actionable project plans, milestones, deliverables, timelines, dependencies, and accountabilities.
• Lead the planning and execution of complex regulatory projects and submissions, ensuring end-to-end delivery from preparation through submission, approval, and health authority feedback.
• Create and continuously update critical paths for regulatory submissions, incorporating internal and external events, dependencies, and key milestones.
• Track and report project performance metrics, including milestones, timelines, resourcing, documentation, submission progress, approvals, health authority feedback, and KPIs.
• Coordinate Submission Deliverable Teams and Regulatory Excellence Team activities, ensuring effective collaboration, alignment, and accountability across stakeholders.
• Hold project team members accountable to agreed plans and commitments while organizing follow-ups and ensuring the right knowledge and resources are available.
• Coordinate regulatory actions and deliverables from pre-IND through MAA submission, including Health Authority interactions, Clinical Trial Applications, Development Safety Update Reports, and related activities.
• Partner with regulatory leadership and cross-functional stakeholders to develop and manage regulatory project plans, timelines, and interdependencies.
• Coordinate with Asset & Evidence teams to collect the data, documentation, and information required for accurate and timely regulatory submissions.
• Support the generation, coordination, and regulatory input of key development, registration, and commercialization documents, including development plans, protocols, clinical trial reports, pediatric development plans, core dossier components, integrated brand plans, and market access materials.
• Proactively identify risks, backlogs, deviations, compliance concerns, and potential delays, bringing relevant stakeholders together to develop recommendations and mitigation strategies.
• Establish effective communication channels, meetings, agendas, minutes, action logs, and tracking mechanisms to maintain transparency and ensure follow-through.
• Support regulatory leadership with preparation and coordination of internal and external meetings, including Health Authority interactions, senior leadership updates, and governance committees.
• Maintain organized repositories of regulatory strategies, project documents, key decisions, Health Authority interactions, questions, inputs, presentations, and project logs.
• Coordinate with local regulatory colleagues and other operational interfaces to maintain consistent communication and ensure regulatory developments, changes, and approvals are effectively communicated.
• Liaise with asset program management teams to coordinate regulatory input and interactions with broader asset strategies and evidence planning.
• Facilitate cross-functional problem-solving and encourage agile practices such as sprint planning, daily stand-ups, retrospectives, and other approaches that improve speed and execution.
• Promote operational excellence, standardization, prioritization, and continuous improvement across regulatory project activities.
• Provide regular updates on regulatory milestones, risks, and their potential impact on broader program timelines and objectives.

• Bachelor's degree in a relevant discipline such as life sciences, pharmacy, chemistry, or Business Administration.
• At least 5 years of progressive experience in the pharmaceutical or biotechnology industry, preferably with a focus on project management.
• Significant experience managing complex projects, cross-functional teams, timelines, dependencies, and deliverables.
• Experience with project management within pharmaceutical or biotech environments.
• Understanding of pharmaceutical development processes and regulatory submissions; direct regulatory experience is advantageous.
• Knowledge of regulatory processes and relevant therapeutic areas is preferred.
• Demonstrated understanding and practical application of project management processes, tools, tracking systems, and databases.
• Familiarity with project management platforms such as Microsoft Project, Asana, or comparable solutions, as well as pharmaceutical industry-specific software.
• Advanced project management certification is preferred.
• Strong understanding and application of Agile principles and practices, with the ability to facilitate agile ways of working in complex environments.
• Strong critical-thinking and problem-solving abilities, with the capacity to influence, negotiate, resolve conflicts, and build alignment.