166 vice president regulatory affairs jobs found

The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron Cellular Medicine, the Oncology and Hematology Clinical Development Units on regulatory strategies for the development of Oncology & Malignant Hematology drug products to ensure all corporate objectives are met within specified timelines and vital state of compliance is maintained. In addition, the position acts as a trusted advisor to senior management regarding Regulatory strategies/processes while developing organizational objectives and, importantly, understanding the impact of decisions across functional areas. As a strategic leader within the Regulatory Affairs organization the incumbent will be instrumental in the evolution of Regeneron's burgeoning Oncology & Hematology medicine development candidates by leveraging cross-functional relationships. In addition, the incumbent will lead strategic development of a highly...

Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic...

Who we are! Elementl Power, a pioneering technology-agnostic advanced nuclear project developer and Independent Power Producer, is on a mission to revolutionize the deployment of nuclear energy by providing comprehensive turn-key development, financing, and ownership solutions. We specialize in facilitating access to clean baseload power, aiming to break the stalemate in traditional energy methods and pave the way for a sustainable energy future. As we eagerly grow our innovative solutions in the nuclear energy field, we're ready to add a Vice President of Regulatory Affairs to our team! In this role, you will lead the Nuclear Regulatory Commission (NRC) activities, ensuring Elementl meets all regulatory requirements associated with planning, development, and implementation of regulatory strategies, licensing, and permitting of advanced nuclear power projects (ANPPs). You will report to the Chief Executive Officer and collaborate closely with our General Counsel and Chief...

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...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $238,500 - $349,800 At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on...

Job Description Join our HR Control Management team today! This team maintains a strong and consistent control environment through a joint accountability model that align managers with each function and region to mitigate operational risk. The team focuses on four areas: Risk Identification & Assessment, Control Design & Evaluation, Issues & Control Deficiencies and Control Governance & Reporting. Control Management serves as an independent function within Human Resources to advise, counsel and assess risk mitigation strategies, in addition to effective evaluation of processes, risks and controls. As a Control Manager - Vice President within HR Control Management team, you will be part of a team that ensures strong and consistent controls are observed across the firm. Reporting to the Product Portfolio Control Lead, you will be responsible for the control framework of one or more sub products within the HR Product Portfolio. You will focus on improving and...

Company Overview Tempero Bio is a clinical-stage biopharmaceutical company developing treatments for substance use disorders and related conditions. Over 40 million people experienced a substance use disorder in the US in the past year, including 28.3 million with an Alcohol Use Disorder (AUD), and 1.3 million with a Cocaine Use Disorder (CUD). There are no medications approved by the FDA to treat Stimulant Use Disorders like Cocaine Use Disorder, and no new treatments have been approved by the FDA to treat Alcohol Use Disorder in the last 16 years. With the development of our lead therapeutic candidate, TMP-301, a potent, orally-available, metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM), we're committed to translating science into innovative medicines that will change the course of treatment in substance use disorders and in turn, revitalize millions of lives. Tempero Bio is a portfolio company of Aditum Bio, a biotech venture capital firm...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 Senior / Vice President, Technical on Parexel's Regulatory Strategy team (RS)! As a Sr/VP, Tech you'll work on a variety of assignments, diverse product types for clients with...

Incredible opportunity to bring your Health Authority experience and Medical Device expertise to Parexel as a Vice President, Technical! D ue to our ongoing success, we expect to be growing our Regulatory Consulting team! In anticipation of these needs, we'd love to connect with Medical Device Regulatory Affairs SMEs who are interested in bringing their dedication to patients and commitment to new and better treatment options to Parexel. The VP-Technical (Medical Device Regulatory Affairs) serves as a luminary in this product area for the Regulatory Consulting business. The VP-Technical (Medical Device Regulatory Affairs) possesses superior knowledge and specialized training in this area, as demonstrated by their prior roles a senior-level member at a Health Authority or in the pharmaceutical industry (e.g., Medical Device Team Leader, Master/Senior Reviewer, Assoc. Director, Section Head etc.). A Technical Vice President must be an internationally recognized professional in...

Purpose: The Vice President of Compliance and Regulatory Affairs will serve as an active member of the executive leadership team, is responsible for compliance with regulatory and legal requirements, and is responsible for development, execution of and supervision of regulatory strategies that support organizational objectives and operations that are compliant with FDA regulations, state requirements, ISO Standards, AATB Standards, and other applicable regulations. Duties & Responsibilities: Define and execute regulatory strategies and solutions in support of company strategic objectives Hold final accountability for decision-making on the matters relating to regulatory compliance for the organization. Plan and oversee (or execute) all FDA, state, and other regulatory/compliance activities Oversee regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, unique device identifiers (UDI), state licenses, etc....

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Summary: We are seeking a dynamic and innovative individual to serve as the Head of Regulatory Legal and lead the Regulatory Legal Team (RLT) at Lilly. This role requires a practical, creative, and collaborative individual with extensive experience in the biopharmaceutical industry with a focus on US FDA and global medicines agencies. The ideal RLT leader has a deep understanding of the relationship between the commercial and the...

MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. Position Summary: The Vice President, Sales & Marketing will be a critical commercial leader, responsible for designing and executing the full commercial strategy for MannKind's Pediatric Endocrinology business. This role holds full accountability for both sales' execution and...

Location : Demorest (Main) Campus Job Type: Full-Time Staff Job Number: 202500109 Division: Administration and Finance Opening Date: 06/11/2025 Founded in 1897, Piedmont University is a private, comprehensive liberal arts university with an enrollment of approximately 2,000 students at campuses in Demorest and Athens, Georgia. Description The Vice President of Finance and Administration/CFO at Piedmont University is a dynamic leader that plays a critical role in shaping Piedmont's financial strategy and ensuring that the university remains innovative and financially sustainable as it grows. At Piedmont, we offer more than just a job - we provide a chance to be part of an institution that dedicates itself to the transformative power of education through reciprocal learning, the development of compassionate leaders, and the stewardship of our local and global communities. Essential Functions and Responsibilities Executive Leadership and Management Serve as a...

Brice Civil Constructors Inc Regular JOB SUMMARY: The Vice President of Corporate Alliances will play a pivotal role in the civil construction business unit and the vertical and structures business unit leveraging over 30 years of contracting experience to foster strategic and tactical partnerships between government and industry. This senior-level position will act as an internal consultant, advisor, and senior counsel on matters related to government acquisitions and contracting. Reporting directly to the civil business unit president, this position will also support other business units in the same or similar capacity. ESSENTIAL FUNCTIONS: Strategic Partnership Development: Establish and maintain strong relationships with government entities and industry partners, ensuring alignment with corporate goals and practices. Government Contracting Expertise: Provide expert advice on government acquisition processes, ensuring compliance and strategic advantage in bidding...

Vice President of Research Administration Location: Bar Harbor, ME ; Portland, ME; or Farmington, CT Application Requirements: Please submit a cover letter and CV. Applications without a cover letter will not be considered. The Vice President of Research Administration (VPRA) of The Jackson Laboratory (JAX) plays a pivotal role in driving the strategic, regulatory, and administrative management activities that underpin JAX's research mission. This executive leader provides comprehensive oversight of operational research activities, ensuring the seamless implementation of policies that foster collaboration across diverse departments and stakeholders. The VPRA is instrumental in championing innovation, compliance, and excellence in all aspects of research administration. Key Responsibilities (What you contribute) Leads the research administration team, ensuring robust support for pre-award activities and faculty initiatives. Drives the implementation of strategic...

About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to...

About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to...

Our Client, a global nonprofit organization on the forefront of saving and healing lives through innovations in tissue and organ donation, transplantation, and research is seeking a VP of Medical Affairs to join their growing team. Summary: This role is fully remote with ~30% travel The Vice President (VP) of Medical Affairs leads the organization's medical strategy, overseeing all medical content, ensuring regulatory compliance, and providing leadership across key functions. This includes managing the Medical Science Liaison team, medical complaint analysis, donor eligibility, and risk assessment for infectious disease transmission. Key Responsibilities: Lead medical policy decisions, advising on patient safety and medical issues to internal teams, clinical partners, and healthcare professionals. Oversee medical aspects of the product portfolio, including approval of clinical publications, policies, and procedures related to tissue safety, donor eligibility, and...

Associate Vice President of Campus Safety/Peace Officer (Armed) Category: Professional Subscribe: Department: Campus Safety Locations: Schenectady, NY Posted: Mar 6, 2025 Closes: Open Until Filled Type: Full-time Position ID: 186127 Share About SUNY Schenectady County Community College: SUNY Schenectady County Community College (SUNY Schenectady) is one of the State University of New York's finest two-year colleges located in upstate New York's vibrant and growing Capital Region, with easy access to Boston, NYC, the Adirondack and Catskill Mountains, Montreal and scenic Hudson Valley, all of which are just a few hours away. SUNY Schenectady is a premier college that provides quality, comprehensive education for transfer, career, training and workforce development to a diverse population in a student centered environment. The College offers more than 50 transfer and career programs in science, aviation, culinary, music, and liberal arts, and serves...

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 670 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...