Senior Regulatory Program Manager

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

📋 Description

• Collaborate with Global Regulatory Leads to design and implement regulatory plans that are aligned globally, both during development and post-marketing phases.

• Convert regulatory strategies into executable plans that include milestones, critical paths, risks, and opportunities.

• Oversee the execution of regulatory plans across international programs.

• Discover innovative regulatory pathways and planning scenarios.

• Work together with cross-functional teams and senior leadership on regulatory deliverables, timelines, and interdependencies.

• Organize and facilitate Global Regulatory Subteam meetings and project review forums.

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

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

• Address regulatory project and operational challenges, implementing scalable solutions.

• Prepare strategic dashboards, reports, and scenario plans for senior stakeholders.

⛳️ Requirements

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

• A minimum of 7 years of progressively responsible experience in the pharmaceutical, biotechnology, or related life sciences sectors, including at least 5 years in regulatory or regulatory program management.

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

• In-depth knowledge of U.S. regulatory requirements along with familiarity with international (non-U.S.) regulations and agency expectations.

• Proven success in managing complex regulatory deliverables across cross-functional teams within a matrixed organization.

• Practical experience with eCTD and the preparation, formatting, and submission strategies for regulatory documentation.

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

• Outstanding communication and influencing abilities, with the capacity to distill complex regulatory information into clear recommendations.

• Strong judgment and adaptability in managing competing priorities, resource limitations, and shifting program demands.

• Familiarity with project management tools and best practices to improve visibility, efficiency, alignment, and meeting effectiveness.

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

• Committed to ongoing learning and improvement, embracing an innovative mindset.

• Advanced skills in Smartsheet and the Microsoft Office Suite.

• Proficient in creating visual presentations using PowerPoint, particularly from timeline integration tools like One Pager and Office Timeline Pro.

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

🏝️ Benefits

• Opportunity to work in a dynamic and innovative environment.

• Competitive compensation and benefits package.

• Professional development and continuous learning opportunities.

• Collaborative team culture that values diversity and inclusion.