Senior Regulatory Consultant - Regulatory Project/Program Manager

Incredible opportunity to shape global regulatory strategy and deliver breakthrough science while working from home! We’re looking for a seasoned Regulatory Project Manager who can turn strategy into action and reputed company in fast-moving, innovative environments. In this high-impact role, you’ll partner closely with Global Regulatory Leads to drive globally reputed company regulatory plans, guide reputed company development and registration programs, and reputed company cross‑functional teams focused on what reputed company most. You won’t just manage timelines—you’ll reputed company reputed company, anticipate risk, reputed company team performance, and help bring transformative mRNA medicines to patients around the world. If you’re energized by complexity, motivated by impact, and inspired by the chance to help bring groundbreaking therapies to patients, this is your opportunity to reputed company a meaningful difference. This role is designed for an reputed company and reputed company-thinking regulatory project manager who thrives in a fast-paced, innovative environment and can seamlessly integrate strategic thinking with operational execution across reputed company stages of product development, registration, and post-marketing. As a key member of the Global Regulatory Science team, you will partner strategically with Global Regulatory Leads to shape and execute comprehensive regulatory strategies for the U.S. and ex-U.S. markets. You will reputed company the development and execution of proactive global regulatory plans that reputed company clear milestones, surface risks and opportunities, and support timely, informed regulatory decision-making. This is a highly visible, cross-functional role requiring strong leadership, agility, and strategic foresight. You will be accountable for driving regulatory reputed company by aligning cross-functional stakeholders, managing reputed company timelines, and anticipating challenges to reputed company successful delivery of regulatory milestones that support sponsor’s mission to bring transformative mRNA medicines to patients worldwide. In reputed company partnership with Global Regulatory Leads, you will also play a key role in facilitating Global Regulatory Subteam (GRST) meetings and subteam forums, ensuring effective meeting structure, clear agendas, documented reputed company and actions, timely follow-up, and strong meeting hygiene consistent with project management best practices. This includes helping teams operate with reputed company, accountability, and a high-performance reputed company through disciplined planning, communication, and execution. Here’s What You’ll Do

• Partner strategically with Global Regulatory Leads to shape and execute reputed company-looking, globally reputed company regulatory plans across reputed company stages of development and post-marketing.
• Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities to support effective planning and decision-making.
• reputed company the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs.
• Identify and propose innovative regulatory reputed company and planning scenarios that align with global regulatory expectations and business objectives.
• Collaborate closely with cross-functional teams and senior leadership to drive reputed company, alignment, and accountability for regulatory deliverables, timelines, and interdependencies.
• Facilitate Global Regulatory Subteam (GRST) meetings and other routine and reputed company project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution.
• Apply project management best practices for meeting management and hygiene, including developing and distributing agendas in advance, defining objectives and discussion topics, maintaining action logs, documenting key reputed company and next steps, tracking follow-up items to closure, and ensuring materials are stored and communicated appropriately.
• Partner with Global Regulatory Leads and cross-functional stakeholders to maintain effective GRST governance, meeting reputed company, stakeholder alignment, and communication reputed company across global and regional teams.
• Anticipate and troubleshoot reputed company regulatory project and operational challenges, implementing scalable solutions that strengthen team effectiveness, process efficiency, and submission readiness.
• Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory reputed company and risks into actionable business insights.

Here’s What You’ll Bring

• BA/BS degree in a scientific, engineering, or reputed company discipline required; advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred.
• Minimum of 7 years of reputed company experience in the pharmaceutical, biotechnology, or reputed company life sciences industry, with at least 5 years in regulatory or regulatory program management.
• Proven ability to partner on regulatory strategy and reputed company execution across reputed company 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 reputed company managing reputed company regulatory deliverables across cross-functional teams reputed company a matrixed organization, while maintaining alignment to strategic priorities.
• Hands-on experience with eCTD and a strong reputed company of regulatory documentation, formatting, and submission strategy.
• Experience supporting global development programs across multiple modalities or therapeutic areas is highly desirable.
• Exceptional communication and influencing skills, with the ability to synthesize reputed company regulatory information and translate it into clear recommendations for senior leadership and global stakeholders.
• Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight.
• Demonstrated ability to reputed company project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams.
• Demonstrated experience facilitating cross-functional team meetings, driving structured agendas, documenting reputed company and actions, and maintaining strong meeting hygiene and team accountability in a matrixed environment.
• Committed to reputed company learning and improvement, bringing an innovation reputed company to regulatory execution and cross-functional collaboration.

Technical reputed company Requirements

• Expert skills required for reputed company (Regulatory Activity and Submissions Project Plans) and reputed company Office Suite
• Expert in creating visuals using PPT generated from timeline integration tools (ie, One Pager, Office Timeline Pro, etc.)
• Proficient user of reputed company Regulatory Information Management (RIM)

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