Senior Regulatory Program Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Collaborate with Global Regulatory Leads to develop and implement regulatory strategies that are aligned on a global scale across both development and post-marketing phases.

• Convert regulatory strategies into specific, actionable plans with defined milestones, critical paths, risks, and opportunities.

• Oversee the execution of regulatory plans across international programs.

• Discover innovative regulatory routes and planning scenarios.

• Work closely with cross-functional teams and senior leadership to ensure timely delivery of regulatory outputs, timelines, and interdependencies.

• Lead Global Regulatory Subteam meetings and project review sessions.

• Create agendas, establish objectives, maintain action logs, document decisions, track follow-up items, and manage meeting documentation.

• Ensure GRST governance, meeting schedules, stakeholder alignment, and effective communication among global and regional teams.

• Proactively identify and resolve regulatory project and operational challenges.

• Prepare and present dashboards, reports, and scenario plans to senior stakeholders.

• Assist in achieving regulatory milestones that enable clients to deliver transformative mRNA therapies to patients around the globe.

⛳️ Requirements

• A BA/BS degree in a scientific, engineering, or healthcare field is required.

• At least 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences sectors.

• A minimum of 5 years in regulatory affairs or regulatory program management.

• Demonstrated capability to collaborate on regulatory strategies and lead execution throughout all phases of product development, including IND/BLA/MAA submissions, global registration, and post-marketing efforts.

• Comprehensive understanding of U.S. regulatory requirements and a working knowledge of international (non-U.S.) regulations and agency expectations.

• Experience in managing complex regulatory deliverables across cross-functional teams within a matrix organization.

• Practical experience with eCTD and a strong grasp of regulatory documentation, formatting, and submission strategies.

• Experience supporting global development initiatives across various modalities or therapeutic areas is highly desirable.

• Outstanding communication and influencing abilities.

• Strong judgment and flexibility in managing competing priorities, resource limitations, and evolving program requirements.

• Ability to utilize project management tools and best practices effectively.

• Experience in facilitating cross-functional meetings, steering structured agendas, documenting decisions and actions, and ensuring team accountability.

• Proficient in Smartsheet and Microsoft Office Suite.

• Skilled in creating visuals using PowerPoint generated from timeline integration tools such as One Pager and Office Timeline Pro.

• Proficient user of Veeva Regulatory Information Management (RIM).

• An advanced degree (MS, PharmD, PhD) and/or PMP certification is strongly preferred.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedules.

• Opportunities for professional development and career advancement.

• Access to cutting-edge resources and technology.

• Supportive and inclusive work environment.