CMC Regulatory Strategist

Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. We are currently hiring a Director, CMC Strategy to join our team! As a Director, CMC strategy, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients’ interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. You will serve as Rho’s senior CMC expert and ensures full CMC support for Rho’s project teams, including CMC-specific project tasks such as developing and tracking project budget, timelines, resources, and deliverables, as well as authoring and reviewing CMC regulatory documents for clinical trial applications and marketing applications, regulatory agency meeting packages, CMC gap analyses, and other documents as needed. Our Regulatory Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!Key Responsibilities:On behalf of Rho’s clients, support and advis e the CMC and related regulatory components of integrated development programs, including the review of technical documents, participation in technical discussions, and collaborations with CDMOs and other vendors.Provide CMC regulatory-related leadership, guidance, and support to a teamMentor and advise Rho staff in CMC regulatory strategy and product development by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team membersProactively identify risks and critically analyze problems affecting the programs and develop contingency plans as neededFacilitate achievement of strategic goals for a programMonitor ongoing progress of key CMC deliverables against Global Integrated Product Development Plan goalsEnsure effective, accurate and timely communication of key issues and progress to the team and senior management Participate in the planning, preparation, and conduct of regulatory authority meetings; lead CMC discussions with regulatory authorities Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; provide guidance and input to the budgets and business submissions of proposals