Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees
Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.
Responsible for leading the strategic direction, management, and oversight of the organization’s regulatory compliance program.
Manage a team of compliance professionals, ensuring that the company operates in full adherence to applicable laws, regulations, and industry standards.
Drive the development and implementation of enterprise-wide compliance frameworks, oversee risk assessments, support regulatory interactions, and champion a culture of compliance across the organization.
Truelogic is a leading provider of nearshore staff augmentation services headquartered in New York. Their team of 600+ highly skilled tech professionals, based in Latin America, drives digital disruption by partnering with U.S. companies on their most impactful projects.
Oversee regulatory operations across our expanding national footprint. Guide state higher education approvals, partner with campus and executive leaders. Shape the regulatory framework that supports our mission to transform nursing education.
Arizona College of Nursing transforms people’s lives by preparing them for careers in nursing and improving communities through the care its graduates provide.
Advise on regulatory compliance matters across jurisdictions.
Support business units on pharmacy operations and supply chain issues.
Assist with responses to regulatory inquiries and complaints.
Hims & Hers is a health and wellness platform that aims to improve people's health through accessible care. They are a public company traded on the NYSE with a talent-first flexible/remote work approach.
Ensure robust compliance across our global operations.
Manage all aspects of regulatory reporting, ensuring accurate and timely submissions across a broad range of regulations.
Lead effective exam management, handling regulatory requests and coordinating internal stakeholders across diverse jurisdictions.
Anchorage Digital is a crypto platform that enables institutions to participate in digital assets through custody, staking, trading, governance and the industry's security.
Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
Lead global regulatory activities for cell therapy programs as the Global Regulatory Lead. Shape regulatory strategy, lead health authority interactions, and support documentation. Collaborate with Clinical, CMC, Nonclinical, Quality, and Program Management teams.
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.