Senior Director, Regulatory Affairs Salary at Melinta Therapeutics Inc BETA

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Job Summary Reports to the Vice President of Research and Development with the primary responsibility to develop and implement comprehensive global regulatory strategies (except Japan) in all stages of clinical development (preclinical to commercial) to ensure timely and successful interactions with global health authorities. Essential Duties and Responsibilities (Include but not limited to the following. Other duties may be assigned.) Preclinical and Clinical Create the development of global regulatory strategies (except Japan). Serves as primary liaison to FDA, HC, and EMA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Establish and maintain relationships with regulatory agencies, actively participating in interactions

Job Summary: Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The candidate will manage and lead submission related activities associated with the US and ex-US fillings for product, ensure timelines are appropriately managed and kept to, and issues are appropriately raised and resolved in a timely manner. Essential Duties and Responsibilities: (Include but not limited to the following. Other duties may be assigned) Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provides oversight to regulatory consultants and vendors where applicable. Provides regulatory strategic support and guidance across all functions. Routinely performs regulatory precedence and competitive intelligence research. Contributes to identification of potential issues/gaps and

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignm

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for the development and implementation of global strategies, ensuring legislation requirements are met. Provides oversight on strategic regulatory decisions and ensures regulatory and cross-functional alignment. Provides oversight

Essential Job Functions: The Vice President, Enforcement Legal is responsible for leading their attorney teams on timely high-impact and noteworthy investigations and disciplinary actions in coordination with other VPs within Enforcement Legal and FINRA's Regulatory Operations partners, as well as managing the performance of the Enforcement attorney teams. The VP works closely with Enforcement's Head of Investigations (VP) in monitoring and advising on investigations in Enforcement and across Regulatory Operations, as well as identifying and monitoring Enforcement matters involving high-risk firms and brokers across the Enforcement program. The VP is responsible for collaborating with Member Supervision and Market Regulation Transparency Services to ensure an efficient investigative process and consistent, timely, and impactful regulatory outcomes. The VP is responsible for leading the attorney teams to collaborate with the investigators in Enforcement and colleagues across Regulatory

Director, Regulatory Risk and Governance Capital One is one of the fastest growing organizations in the world today. As Director for Regulatory Risk and Governance, you will apply your risk management skills and lead a team to assess and implement new and updated laws and regulations that affect Enterprise Services (ES); you will also ensure ongoing regulatory applicability to and compliance of business processes and controls. As an ES Risk Director in the first line of defense, you will partner with compliance, legal, and line of business professionals to review and assess the applicability of a broad range of new or changed laws and regulations to the highly diverse ES businesses, including digital products and services, facilities, security, procurement, external affairs, investment ventures, software, technology, and brand. In doing so, you will lead a team to be responsible for investigating business practices, communicating impacts to business partners, and driving implementation

Overview: Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japans most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinsons (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPAs commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others. You