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Manager Regulatory CMC Strategy (Remote - Anywhere) at Jobgether. This position is posted by Jobgether on behalf of Accede Solutions Inc. We are currently looking for a Manager Regulatory CMC Strategy in Anywhere.. Join a dynamic and collaborative environment where you will play a key role in shaping global regulatory CMC strategies across the product lifecycle. This position involves preparing high-quality regulatory submissions, collaborating with cross-functional teams, and ensuring regulatory compliance across multiple regions. It is ideal for a scientifically driven professional who thrives in a fast-paced, deadline-oriented setting, with the opportunity to make a measurable impact on global product success.. Accountabilities:. . Develop and execute regulatory CMC strategies aligned with global requirements for submissions, approvals, and lifecycle management.. . Lead resolution of complex issues, enabling informed decision-making in partnership with internal and external stakeholders.. . Collaborate with R&D, Quality, and Regulatory Affairs teams to align on submission content and timelines.. . Author and review regulatory CMC submissions including new registrations, variations, renewals, and responses to agency queries.. . Ensure accuracy and regulatory compliance of technical documentation and drive timely fulfillment of CMC-related commitments.. . Represent CMC on project teams, oversee project execution, and manage assigned regulatory portfolios with minimal supervision.. . Mentor junior team members and contribute to broader regulatory or organizational initiatives as needed.. . . Bachelor’s degree in a scientific discipline (minimum); an advanced degree (MS, PhD, PharmD) is preferred.. . At least 6 years of pharmaceutical industry experience, including a minimum of 2 years in CMC regulatory authoring.. . Solid understanding of pharmaceutical development, manufacturing processes, and cGMP compliance.. . Experience with lifecycle management, global regulatory submissions, and post-approval change management.. . Strong verbal and written communication skills; comfortable interacting with diverse technical and regulatory audiences.. . Proficiency in Microsoft Office and regulatory documentation systems (e.g., Documentum).. . Company Location: United States.