Set submission strategy and operational timelines.
Build, evolve, and manage the Regulatory Operations infrastructure.
Establish and oversee training on RA procedures and submission standards.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Serve as a strategic document partner for assigned functional areas, aligning document development and records management with business, quality, and regulatory expectations
Conduct document impact and needs analyses and supports the functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives
Leverage automation, digital tools, and emerging technologies, including AI and Machine Learning, to optimize documentation processes and content
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They have sites in North America, Europe, Australia, Latin America and the Middle East and are consistently recognized as one of the industry's top places to work.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Lead and support Eli’s scientific publishing efforts.
Draft, edit, and prepare scientific documents for submission.
Work closely with Eli’s Medical Director and senior clinicians/scientists.
Eli Health is making continuous hormone monitoring possible so users can support their daily and long-term health. They are a small team of fewer than 20 people, where employees drive their own work and think creatively to solve open-ended problems.
Prepare regulatory filings, conduct routine audits, and organize documentation for legal reviews.
Collaborate with attorneys and business leaders to support compliance initiatives and respond to regulatory inquiries.
Provide guidance to internal stakeholders on compliance requirements.
AffirmedRx aims to improve healthcare outcomes by bringing clarity, integrity, and trust to pharmacy benefit management. They are committed to making pharmacy benefits easy to understand, straightforward to access, and always in the best interest of employers. and the lives they impact.