Senior Regulatory Program Manager
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Job Description
Senior Regulatory Program Manager advancing global mRNA medicine development, registration, and post-marketing plans. Coordinating regulatory strategy, submissions, governance, and cross-functional execution.
Responsibilities:
- 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
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