Senior Regulatory Program Manager

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

📋 Program Manager

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This company has sponsored H1B visas in the past.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Partner with Global Regulatory Leads to shape and execute globally aligned regulatory plans across development and post-marketing • Translate regulatory strategy into actionable plans with milestones, critical paths, risks, and opportunities • Lead execution of regulatory plans across global programs • Identify innovative regulatory pathways and planning scenarios • Collaborate with cross-functional teams and senior leadership on regulatory deliverables, timelines, and interdependencies • Facilitate Global Regulatory Subteam meetings and project review forums • Develop agendas, define objectives, maintain action logs, document decisions, track follow-up items, and manage meeting materials • Maintain GRST governance, meeting cadence, stakeholder alignment, and communication across global and regional teams • Troubleshoot regulatory project and operational challenges and implement scalable solutions • Prepare strategic dashboards, reports, and scenario plans for senior stakeholders

🎯 Requirements

• BA/BS degree in a scientific, engineering, or healthcare discipline required • Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management • Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities • Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations • Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization • Hands-on experience with eCTD and regulatory documentation, formatting, and submission strategy • Experience supporting global development programs across multiple modalities or therapeutic areas highly desirable • Exceptional communication and influencing skills, with ability to synthesize complex regulatory information and translate it into clear recommendations • Strong judgment and agility managing competing priorities, resource constraints, and evolving program needs • Experience leveraging project management tools and best practices to enhance visibility, efficiency, alignment, and meeting effectiveness • Experience facilitating cross-functional meetings, driving structured agendas, documenting decisions and actions, and maintaining team accountability • Committed to continuous learning and improvement with an innovation mindset • Expert skills in Smartsheet and Microsoft Office Suite • Expert 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)