Regulatory Affairs Project Manager​/Sr. Manager

The Regulatory Affairs Project Manager/Sr. Manager leads and coordinates cross-functional regulatory programs supporting pharmaceutical, biotechnology, and medical device products. In this role, you serve as the regulatory project management lead for complex development and commercialization initiatives, with primary responsibility for regulatory planning, execution, submission readiness, and program coordination.

The Regulatory Affairs Project Manager/Sr. Manager partners closely with Regulatory Affairs, Quality, Clinical, CMC, Manufacturing, R&D, and Commercial teams to ensure timely execution of regulatory deliverables and alignment with global regulatory and business objectives. This role requires strong project management capabilities, knowledge of pharmaceutical Chemistry, Manufacturing, and Controls (CMC) requirements, experience with FDA New Drug Application (NDA) filings, and working knowledge of medical device regulatory requirements.

• Lead cross-functional regulatory project teams to ensure timely planning, execution, and delivery of regulatory milestones.
• Develop, maintain, and communicate integrated regulatory project plans, timelines, risks, dependencies, and resource requirements.
• Coordinate activities supporting FDA NDA submissions, amendments, supplements, annual reports, and other regulatory filings.
• Manage regulatory deliverables associated with CMC development programs, coordinating manufacturing, analytical, quality, and regulatory stakeholders to ensure submission readiness.
• Facilitate regulatory submission planning, content development, document collection, review cycles, and milestone tracking.
• Monitor project risks and dependencies, develop mitigation strategies, and elevate critical issues to leadership as appropriate.
• Support implementation of regulatory strategies throughout product development and lifecycle management activities.
• Coordinate EU Medical Device Regulation (EU MDR) implementation projects, including gap assessments, remediation activities, technical documentation planning, and stakeholder engagement.
• Drive cross-functional collaboration among Regulatory Affairs, Quality Assurance, Clinical Affairs, R&D, Operations, and external partners.
• Lead project governance meetings, document decisions and action items, and communicate project status, risks, and key milestones to management and executive stakeholders.
• Develop and maintain project metrics, dashboards, and reporting tools to provide visibility into regulatory program performance and execution.
• Support regulatory inspection and audit readiness initiatives, as applicable.
• Ensure regulatory project activities comply with applicable FDA, EU, and global regulatory requirements, company procedures, and quality systems.

This individual contributor role is responsible for driving the effective planning, coordination, and execution of complex regulatory programs across product development and commercialization activities. The position requires the ability to manage multiple interdependent regulatory work streams, coordinate diverse cross-functional stakeholders, identify and mitigate project risks, and maintain visibility into critical regulatory milestones and deliverables.

Success in this role requires strong regulatory knowledge, particularly within pharmaceutical CMC and FDA submission processes, combined with disciplined project management, communication, facilitation, and stakeholder management capabilities. The ability to influence cross-functional teams without direct authority and effectively communicate program status and risks to both working teams and executive leadership is essential.

• Bachelor’s degree in a scientific discipline,…