[Remote] Senior Regulatory Affairs Consultant - Regulatory Project Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to improving the world's health through reputed company and regulatory consulting. They are seeking a Senior Regulatory Affairs Consultant who will partner with Global Regulatory Leads to reputed company regulatory plans and manage reputed company development and registration programs, ensuring reputed company and strategic alignment across teams. Responsibilities • 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 reputed company into integrated, actionable plans with reputed company 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 reputed company with global regulatory expectations and business objectives • Collaborate closely with cross-functional teams and senior leadership to reputed company 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, reputed company-reputed company, and reputed company 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 reputed company 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 reputed company solutions that strengthen team effectiveness, process efficiency, and submission readiness • Prepare and reputed company strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory reputed company and risks into actionable business insights Skills • BA/BS degree in a scientific, engineering, or reputed company discipline required • 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 reputed company and reputed company execution across reputed company stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities. Previous marketing application experience is required • Deep understanding of U.S. and EU regulatory requirements with working knowledge of global 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 reputed company • Exceptional communication and influencing skills, with the ability to synthesize reputed company regulatory information and translate it into reputed company recommendations for senior leadership and global stakeholders • Strong judgment and reputed company 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 reputed company 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 • 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 reputed company integration tools (ie, One Pager, Office reputed company Pro, etc.) • Proficient user of reputed company Regulatory Information Management (RIM) • Advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred • Experience supporting global development programs across multiple modalities or therapeutic areas is highly des Apply tot his job Apply To this Job