Regulatory Affairs Project Manager/Sr. Manager

How You’ll Contribute

• 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 escalate 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.

What It Takes

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 workstreams, 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.

What You Bring

• Bachelor’s degree in a scientific discipline, engineering, pharmacy, life sciences, or a related field.
• 5+ years of experience in regulatory affairs, regulatory operations, regulatory project management, or a related function within the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated knowledge of FDA New Drug Application (NDA) submission requirements and processes.
• Strong understanding of pharmaceutical Chemistry, Manufacturing, and Controls (CMC) development, documentation, and regulatory requirements.
• Demonstrated experience managing complex, cross-functional regulatory programs involving multiple stakeholders and competing priorities.
• Working knowledge of medical device regulatory requirements and quality systems.
• Experience developing and managing project plans, timelines, budgets, risks, dependencies, and resource requirements.
• Strong organizational, communication, facilitation, and stakeholder management skills.
• Demonstrated ability to influence and coordinate cross-functional teams without direct authority.
• Proficiency with project management tools and Microsoft Office.

Nice to Have

• PMP certification or equivalent project management certification.
• Experience supporting both pharmaceutical and medical device development programs.
• Direct experience with NDA, BLA, IND, and/or global regulatory submissions.
• Knowledge of EU MDR requirements and experience coordinating implementation activities.
• Familiarity with regulatory information management systems and electronic submission platforms.
• Experience interacting with FDA, Notified Bodies, and other global regulatory authorities.
• Experience supporting combination products, biologics, regenerative medicine, or advanced therapy products.
• Demonstrated success leading global regulatory initiatives in a fast-paced biotechnology or medical technology environment.