Senior Regulatory Program Manager

🕒 August 28

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

📋 Program Manager

🦅 H1B Visa Sponsor

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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 • Anticipate and troubleshoot regulatory project and operational challenges • Prepare and deliver dashboards, reports, and scenario plans to senior stakeholders • Support regulatory milestones enabling clients to bring transformative mRNA medicines to patients worldwide

🎯 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 • 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 and working knowledge of international (ex-U.S.) regulations and agency expectations • Experience managing complex regulatory deliverables across cross-functional teams within a matrixed organization • Hands-on experience with eCTD and strong command of regulatory documentation, formatting, and submission strategy • Experience supporting global development programs across multiple modalities or therapeutic areas highly desirable • Exceptional communication and influencing skills • Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs • Ability to leverage project management tools and best practices • Experience facilitating cross-functional meetings, driving structured agendas, documenting decisions and actions, and maintaining team accountability • 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) • Advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred