Associate Consultant, Regulatory Operations

Red Nucleus is expanding the R&D team and hiring a Director or an Associate Director, Regulatory Operations. This role can be remote based in the US. COMPANY DESCRIPTION: Red Nucleus is a premier provider of global solutions for R&D, Medical Affairs, Value & Evidence, and Commercial teams within biopharmaceutical, medical device, and diagnostics industries. Squarely focused on the life sciences industry for more than 30 years, Red Nucleus takes pride in our long-term relationships with industry leaders, as well as our strategic partnerships with innovative startups. We are focused on developing thoughtful, high-quality solutions that are in accordance with each client’s unique culture and needs. Our clients trust us to build impactful, award-winning programs that deliver actionable insights and measurable results. Job Overview: Associate Consultant is responsible for providing hands-on expertise and operational support in the planning, preparation, and delivery of high-quality regulatory submissions in accordance with global health authority requirements. This role partners closely with regulatory leads and cross functional teams to ensure submission content is complete, accurate, and delivered on time. Responsibilities: · Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information · Manage regional submissions and support global submissions · Proactively communicates requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines · Proactively collect necessary information from the Submission Team · 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 RN standards · Participate on special project teams (e.g., skill work, standards). Education, Experience, Training, and Knowledge Education: · Bachelor’s degree in Life Sciences, Business, or related field required, Master’s degree preferred Experience: · 3-5 years of experience in management consulting, life sciences strategy roles, or a relevant field. Skills & Abilities: · Strong analytical and problem-solving capabilities. · Rigorous attention to detail and accuracy · Self-starter and driven · Ability to multi-task with superior organization skills · Strong ability to work independently as well as be an integral part of a team · Dependable and flexible · Excellent written, verbal communication, and time management skills · Proficient in Microsoft Suite software including Project, Excel, Word, PowerPoint, Visio · Ability to work in a global environment with an understanding of cultural differences and work practices #LI-LD1 Apply tot his job