Regulatory Affairs Coordinator Salary in Chicago, Illinois

Company Capstone, a fast-growing, private equity-owned pharmaceutical company; develops complex generic products, internally and for commercial partners, located in Rosemont, IL https://www.capstonedevservices.com/ Overview Responsible for preparing, implementing, communicating, and coordinating US and global regulatory strategy in collaboration with project team members. Collects, prepares and assembles documentation required to initiate, submit and maintain 505(b)(2) NDA, ANDA and MA Applications in eCTD format. Primary Responsibilities Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives. Evaluate regulations, establish framework, and design and implement science-based registration strategies for products to ensure rapid, high quality submissions. Monitor product-related activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices. Review supporting documentation required i

Department: MED-Ophthalmology Salary/Grade: EXS/7 Job Summary: Oversees the Department of Ophthalmology research program; provides direction and thought leadership to develop strategic administrative initiatives that meet the research mission of the department. Oversees the effective, compliant, & efficient daily management of all operational, financial, & business functions in support of the research program & in coordination with central offices such as Sponsored Project and Research Catalysts (SPARC) and Northwestern University Clinical and Translational Sciences Institute (NUCATS). Represents the research program on internal & external business affairs & is viewed as an expert resource regarding the research program administrative affairs. Leads the clinical research coordinator team and manages a variety of tasks related to collaboration studies and study startup. Specific Responsibilities : Administration •Directs and leads development of program/project strategic plan. •Oversees

Overview: The Senior Manager, Regulatory Affairs Advertising & Promotion is responsible for directing the regulatory aspects of internal and external communications including advertising and promotional activities. They will coordinate the development and implementation of regulatory strategies for promotion and advertising plans and are a leader in the review process to support approval and dissemination of marketed product promotional material. Liaises with FDAs Office of Prescription Drug Promotion (OPDP) for Advertising and Promotion submissions. Responsibilities: Leads the development and oversight of the processes and procedures relevant to the creation, review, and approval of advertising and promotional materials as part of Xeris Regulatory review process and other external communication to ensure regulatory compliance. Leads the development and oversight of the processes and procedures relevant to the creation, review, and internal approval of FDA-approved prescribing informat

Company Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We're fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make a

Invenergy drives innovation in energy. Powered by decades of entrepreneurial experience and unparalleled execution, we solve the energy challenges facing our customers and communities. We provide power generation and storage solutions at scale around the world to create a cleaner energy future. We develop. We build. We own. We operate. We are Invenergy. Job Description Position Overview As a Vice President, East Origination, you will be responsible for leading and driving Invenergy's origination activities in the East, generally including all or portions of MISO, PJM, SERC, NYISO, and Canada. The VP, East Origination will maintain, develop, and grow utility customer relationships with the ultimate objective to execute offtake agreements including Power Purchase Agreements for new-build and existing assets, as well as Build Transfer Agreements and Development Transfer Agreements for new assets. This role will be responsible for market strategy development and execution in close collabor

Center 3 (19075), United States of America, McLean, Virginia Manager, Cyber Risk & Analysis (Machine Learning) The Enterprise Services Business Risk Office provides risk management support to several lines of business including: Tech, Digital, Brand, Enterprise Supplier Management, Capital One Ventures, External Affairs, Capital One Software (COS) and Enterprise ML. We are on the cutting edge of risk management and provide support for new and emerging technologies as well as critical business strategies. Capital One has taken a bold journey to build a technology company, while operating in a complex, highly regulated business. At Capital One, we believe that Machine Learning (ML) represents the biggest opportunity in financial services today, and is a chance to revolutionize the industry. Capital Ones commitment to Machine Learning has sponsorship from leadership and the Enterprise ML Program is at the heart of this effort, and is leading the way towards building responsible and impact