Source Job

• 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.

• Shape and execute regulatory strategy across North America in the clean energy sector.
• Direct a team responsible for navigating complex legislative and policy landscapes.
• Engage with regulators, utilities, and industry stakeholders while supporting the growth of innovative programs.

This position is posted by Jobgether on behalf of a partner company; they use an AI-powered matching process to ensure your application is reviewed quickly.

• Represent Iovance Medical Affairs as a TIL cell therapy expert in both internal and external venues.
• Provide high quality clinical input and review of disease strategy plans, slides, manuscripts and educational materials.
• Partner with Scientific Communications to develop timely publication strategies and plan, gap analysis, and key messages.

Iovance Biotherapeutics is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, their employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

The Regulatory Document Coordinator will have primary responsibility for document management activities supporting Regulatory Affairs. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management. This position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development.

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care

• 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 the strategy and execution of regulatory and quality frameworks.
• Oversee regulatory submissions, including 510(k) and De Novo.
• Ensure compliance with FDA, ISO 13485, and MDR.

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan.

The Upstream Senior Clinical Program Manager will design and execute pre-market feasibility and pivotal clinical studies, ensuring regulatory compliance while supporting marketing claims. This role requires close collaboration with physician collaborators and internal stakeholders to collect, analyze, and interpret clinical data. The role offers remote flexibility, with occasional travel for on-site meetings and conferences.

This position is posted by Jobgether on behalf of a partner company.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

The Medical Director oversees clinical trials, data collection, and protocol implementation. Manages program development, working cross-functionally with various disciplines. Supports data analysis and contributes to the preparation of abstracts, presentations, and manuscripts.

Iovance is committed to cultivating and offering a diverse and inclusive work environment as an equal-opportunity employer.