183 vice president regulatory affairs jobs found

Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary Tango has an exciting new opportunity to join the team as a Vice President, Regulatory Affairs. Reporting to the President, R&D, the VP, Regulatory Affairs will lead Regulatory Affairs for Tango Therapeutics, and will drive the development of innovative global regulatory...

The Vice President of Regulatory Affairs, Risk Management and Patient Centered Services reports to the President of VCU Medical Center and is responsible for VCU Health's overall strategic direction for Regulatory Accreditation and Licensure, Risk Management, and Patient Centered Services. The role is responsible for ensuring VCUHS complies with all complex healthcare regulations, manages risk effectively, and maintains a high level of patient experience and service culture in line with VCU Health Systems mission and vision. Essential Job Statements Ensure VCU Health System complies with all accreditations, federal and state regulatory and licensing standards, including but not limited to, The Joint Commission, Center for Medicare and Medicaid Services, FDA, OSHA, Virginia Department of Health and Virginia Department of Behavioral Health and Development Services Develop, implement, and update policies and procedures to ensure compliance with healthcare regulations and industry...

About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry...

Vice President, Regulatory Affairs and Quality Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize their therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines and antibodies (including bispecifics) and immune cell engagers (including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers). Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.) SUMMARY: The Vice-President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company,...

Job Description JOB SUMMARY The Vice President of Regulatory Affairs & Quality Assurance is responsible for directing the Company's global regulatory and quality assurance strategies. The VP establishes the organization's goals and objectives regarding regulatory affairs and quality assurance and ensures they are achieved. This individual is responsible for leading all submissions and communications with regulatory authorities and managing international submissions and responses. Additionally, this individual will drive the activities of the quality assurance program with a view towards phase-appropriate documentation, developing and managing internal training and SOPS, continuous improvement and implementation of corrective and preventive actions. In this role, the VP ensures that documentation requirements for products and processes are established through change control and assures ongoing maintenance of the Quality Assurance System. This individual has the overall...

Location: Onsite in West Lafayette, IN While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments). SUMMARY: RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation,...

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth. As the new SVP of Regulatory Affairs, the successful candidate will lead the regulatory team in developing and implementing global regulatory strategies for the company's pipeline products as they expand beyond the USA. The ideal applicant should have a successful record in registering biosimilars and be able to commute to New Jersey on a 25% basis. Responsibilities Develop global regulatory strategies to gain earliest possible regulatory approval in US and other international markets with product labelling that sets a high hurdle...

Company Overview: Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company developing and delivering innovative therapies in critical care and infectious disease. Our approved treatments are indicated to address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant pathogens. Innoviva currently has three marketed medicines - GIAPREZA® (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock , XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI), and XACDURO® (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Our investigational therapy, Zoliflodacin is a potential...

At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. Position Summary: MannKind Corporation is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs. Reporting to MannKind's Chief Medical Officer, this position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. They will be a key member of the project leadership teams and will help to inform the design and execution of clinical trials, as well as manage all regulatory submissions for the company. This individual will direct and coordinate activities in regulatory and work with the executive team in formulating strategy, enhancing performance, and administering relevant policies around...

Business Overview: BNP Paribas has been present in the Americas for more than a century. As we have grown in the region, our multi-billion-dollar platform spanning North and South America offers a range of banking, investment and financial services solutions, employing nearly 5,700 people. Our largest business, Corporate and Institutional Banking (CIB), headquartered in New York, operates across the US, Canada and Latin America, in addition to a global reach through a network of offices in EMEA and APAC. CIB offers tailored solutions in financing, cash management, and advisory services to companies via Corporate Banking, in capital markets via Global Markets, and in securities custody and administration via Securities Services. The US is an integral part of the Bank's international network, and in addition to CIB services, our asset management arm offers value-added investment products to companies and institutional investors. Through our partner companies, we can also offer...

"I can succeed as the Vice President, Government & Regulatory Affairs at Capital Group." As the Vice President, Government & Regulatory Affairs based in our Washington, DC office, you will be responsible for leading the development and implementation of a regulatory engagement program for Capital Group that integrates internal and external stakeholders to promote the firm's business objectives. Primary responsibilities: You will be responsible for creating and executing strategies and plans, in partnership with colleagues in Capital Group's Government Affairs and Legal and Compliance teams, to achieve the firm's advocacy objectives. You will build and foster meaningful relationships with regulatory policymakers at the state, federal, and international levels. Relevant policymakers include those at the Securities and Exchange Commission, the Department of Labor, the Federal Trade Commission, the Financial Stability Oversight Council, the Financial Stability Board,...

As one of our ex-FDA colleagues describes it: "you get to see a lot of cool stuff very quickly". If you're looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there's no better place to be than as a Vice President, Technical on Parexel's Regulatory Strategy team (RS)! As a VP, Tech you'll work on a variety of assignments, diverse product types for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home. As a critical member of Parexel's Regulatory Strategy team, you'll be creating opportunity for clients throughout the product lifecycle. Sharing your scientific, technical, regulatory and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators' requirements. You'll be meeting new situations and learning all the time. In fact, one of the key characteristics you'll see...

Company Overview: Based in San Diego, CA, our client is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Join our dynamic team and be part of the transformative journey! Position Overview: We are in search of an accomplished and dynamic Senior Director of Regulatory Affairs to join our team. This pivotal role will spearhead regulatory strategies and activities concerning the development and approval of cell therapy products. Reporting directly to the Chief Medical Officer, the Senior Director will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives. Key Responsibilities: Lead strategic planning and execution of clinical regulatory strategies, agency interactions, and submissions. Collaborate with the Executive team to define regulatory...

About Radionetics Radionetics Oncology, Inc. is a clinical stage company focused on the discovery and development of novel radiopharmaceuticals for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics. Radionetics Oncology is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments and has entered into a strategic agreement with Eli Lilly. Radionetics is advancing a pipeline of first-in-class small molecule radioligands targeting G protein coupled receptors for the treatment of a broad range of cancers, including breast cancer, lung cancer, and other indications of high unmet need. For more information, visit https://radionetics.com. Position summary The Vice President / Senior Vice President, Regulatory Affairs (VP/SVP) is the functional head leading regulatory activities on behalf of the Company. The VP/SVP is the Company point of...

Current employees and contingent workers click here to apply and search by the Job Posting Title. Clear Channel Outdoor Job Summary: Strategically manage and grow the region's portfolio of real estate assets while successfully navigating the federal, state, & local regulatory environment and making strategic / tactical decisions about site location, entitlements, design, budgeting, construction and/or acquisition of real estate assets. Job Responsibilities: Manages existing real estate assets to secure cash flow; minimize site lease, real estate, and some public affairs expenses; employ capital monies for new construction and acquisitions; and maximize value of assets in condemnation. Prepare monthly & quarterly reports. Oversees real estate matters, including policies, and procedures to protect the existing real estate inventory; and work with others to effect laws and public sentiment that is friendly to the company/industry. Prepare quarterly Real Estate and...

Larimar Therapeutics, Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has about 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes...

Vice President, Legal Affairs Location: Syracuse, New York or Washington, D.C. Salary: $150,000 - $200,000 USD plus benefits Relocation Assistance will be offered, if required. About Near East Foundation (NEF) Near East Foundation (NEF) collaborates with local partners to facilitate innovative, sustainable, and community-driven economic and social development across the Middle East, Africa, and the Caucasus, with the goal of establishing more prosperous, inclusive, and resilient communities. NEF empowers marginalized individuals and communities to acquire new skills and access resources, networks, and opportunities, enabling them to shape a future where they can overcome vulnerability to poverty, economic and social disparities, conflict, climate change, and environmental degradation. Mission and Impact Since its founding in 1915, NEF has pioneered strategies in international development, emphasizing education, economic development, and community organizing. Their mission...

Lourdes University, rooted in Catholic and Franciscan traditions, provides a values-centered education that enriches lives and advances academic excellence through the integration of the liberal arts and professional studies. Our diverse community combines faith with reason to develop whole persons of integrity, equipped for a life of service to society. From its establishment in 1958 by the Sisters of St. Francis, Lourdes has provided an excellent Catholic and Franciscan education. Now a campus of 1,200 students, Lourdes offers 44 programs at the Associates, Bachelors, Masters, Doctoral level to students from 34 states and 8 countries. The primary responsibility of the Vice President for Finance and Administration/Chief Financial Officer (VPFA/CFO) is to plan, direct, and monitor the business operations and operational activities of the financial functions for Lourdes in the promotion and fulfillment of its mission and vision. This will include providing leadership and oversight...

About Teneo Teneo is the global CEO advisory firm. We partner with our clients globally to do great things for a better future. Drawing upon our global team and expansive network of senior advisors, we provide advisory services across our five business segments on a stand-alone or fully integrated basis to help our clients solve complex business challenges. Our clients include a significant number of the Fortune 100 and FTSE 100, as well as other corporations, financial institutions and organizations. Our full range of advisory services includes strategic communications, investor relations, financial transactions and restructuring, management consulting, physical and cyber risk, organizational design, board and executive search, geopolitics and government affairs, corporate governance, ESG and DE&I. The firm has more than 1,600 employees located in 40+ offices around the world. Description: A Vice President within Teneo Strategy is responsible for maintaining...

About Teneo Teneo is the global CEO advisory firm. We partner with our clients globally to do great things for a better future. Drawing upon our global team and expansive network of senior advisors, we provide advisory services across our five business segments on a stand-alone or fully integrated basis to help our clients solve complex business challenges. Our clients include a significant number of the Fortune 100 and FTSE 100, as well as other corporations, financial institutions and organizations. Our full range of advisory services includes strategic communications, investor relations, financial transactions and restructuring, management consulting, physical and cyber risk, organizational design, board and executive search, geopolitics and government affairs, corporate governance, ESG and DE&I. The firm has more than 1,600 employees located in 40+ offices around the world. Description: A Vice President within Teneo Strategy is responsible for maintaining...