Regulatory Program Manager – FSP Client Dedicated

🔥 2 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

📋 Program Manager

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 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 regulatory plan execution 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 flow • Troubleshoot regulatory project and operational challenges and implement scalable solutions • Prepare and deliver dashboards, reports, and scenario plans to 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 • Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs • Experience leveraging project management tools and best practices • Experience facilitating cross-functional team 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

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