Consultant, Regulatory Submissions Manager - Now Hiring

Salary: Red Nucleus is hiring a Regulatory Submissions Manager to join our global team! This role can be full-time remote in the US. Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 700 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space. At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a "Great Place to Work". How You Will Contribute In this position, you will be working with our Scientific Services & Advisory team. For more information about our team, please visit SS&A I Red Nucleus. Red Nucleus R&D Operations team is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs. Red Nucleus is seeking motivated individuals to join a team of consultants committed to delivering quality results to their clients and their businesses. Consultants and Managers will work with Red Nucleus Partners and other team members to help organizations solve issues, create value, maximize growth and improve business performance. Responsibilities You will be working alongside partners, subject matter experts and industry specialists to ensure that all client deliverables meet customer expectations. You will be expected to actively contribute to business transformation, process optimizations and system improvements. The role will require you to represent Red Nucleus and address the client's business requirements and needs including: * Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information. * Project Management across all R&D contributors to global submissions * Manage regional submissions and support global submissions as a Lead Publisher * Manage and/or mentor junior team members * Proactively communicate requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines. * Proactively collect necessary information from the Submission Team, and plan all submission management related activities. * Proactively communicate with clients on submission requirements including eCTD * Liaise with agency experts on electronic submission requirements * Perform quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards. * Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools. * Analyze submissions and track and record life-cycle information in accordance with standards. * Perform complex searches on submission life-cycle information, as required. * Keep updated on regulatory authorities' requirements on technical/format aspects of submissions worldwide and ensure their incorporation into Red Nucleus standards. * Participate on or lead special project teams (e.g., skill work, standards). About You * 8-10 years of experience in the pharmaceutical industry with a focus in Regulatory Operations. * 8-10 years of experience publishing, submitting and managing documents and submissions in a document repository. * Experience in project managing major (NDA, MAA, etc.) submissions. * Understanding of drug development documents. * At least 5 years of experience with publishing * At least 5 years of experience with regulatory global registration management information and systems. * Experience assisting with the implementation of a regulatory technology such as, Documentum, First Docs, Insight Manager, Insight Publisher, etc. * Experience assisting in the migration of documents and submissions from one regulatory system technology to another. * Proficient in Microsoft Suite software including Excel, Word, Powerpoint, Visio * Bachelors degree preferred Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status. To learn more about working at Red Nucleus, please visit Careers I Red Nucleus. #LI-TE1 #LI-Remote remote work