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Senior Regulatory Program Manager
Thermo Fisher Scientific. Partner with Global Regulatory Leads to shape and execute globally aligned regulatory plans across development and post-marketing .
About the role
Key responsibilities & impact- 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
What you’ll need- 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)