Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Build and scale the "Technical Playbook" for medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Serve as embedded regulatory thought partner to Clinical and Operations teams, providing real-time guidance.
Partner with Clinical and Compliance team on policy development, audit response, and remediation strategies.
Translate complex healthcare regulations into practical guidance and tools.
Headway is building a new mental healthcare system everyone can access by solving the biggest barrier to care: insurance. They have over 75,000 providers across all 50 states run their practice on their software, serving over 1 million patients.
Works collaboratively within CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs.
Contributes to drafting, reviewing, and finalizing CMC content and regulatory documents such as Module 3 sections for INDs, BLAs, and MAAs.
Plans and manages writing projects, ensuring documents meet quality standards and adhere to corporate SOPs and evolving global regulations.
Iovance Biotherapeutics aims to be the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are an innovative biotechnology company pioneering a transformational approach to treating cancer by harnessing the human immune system.
Author, review, and manage clinical, regulatory, technical, and medical documents including protocols, study reports, and regulatory submissions.
Ensure strategic alignment and consistency of scientific messaging across documents while maintaining compliance with global regulatory requirements.
Drive the end-to-end writing process, manage timelines, and lead cross-functional reviews to deliver high-quality, on-time deliverables.
Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, focusing on cardiovascular indications. The company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders, empowering talented individuals to make a real impact.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports 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.
Partner with Regulatory leads to manage regulatory filing subteams and subteam operations.
Develop and maintain high level and detailed regulatory timelines that utilize project management software tools.
Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays.
Ultragenyx is a biopharmaceutical company committed to addressing unmet medical needs in the field of rare diseases. With a focus on innovation and patient-centricity, they strive to develop life-changing treatments and improve the lives of patients and caregivers.
Responsible for CMC regulatory activities globally for assigned projects and adapts swiftly to changing events and priorities.
In charge of CMC strategy development, with management support, for CMC submission dossiers to support lifecycle management.
Ensures that information submitted in support of life cycle maintenance applications meets regional requirements, allowing maximum flexibility in supply, manufacturing and quality.
Alphanumeric recruits for one of the largest pharmaceutical companies in the world, headquartered in Montreal, Quebec. They are helping them find a Responsable des affaires réglementaires internationales CMC to work remotely in Quebec or Ontario.
Develop a deep understanding of customer workflows.
Champion Qualio's agentic compliance solutions.
Become an in-house expert on Qualio's product.
Qualio is an agentic quality and compliance management platform that helps regulated organizations get products to market faster with reduced risk. The Qualio team is an all-remote, globally distributed workforce with teammates in over ten countries.
Own a portfolio of jurisdictions and act as the operational lead for everything regulatory that happens in those geos.
Partner closely with engineering and product to drive requirements development and shape how registration and compliance products are customized per market.
Translate policy and legal direction into operational playbooks and translate field signal back into product priorities.
Breezy is a global, two-sided marketplace company.
Preparation of Initial Investigational New Drug (IND) applications and amendments.
Provide guidance and support to other in‑house units in the preparation or review of manuals, training guidelines, and similar documentation.
Serve as a resource for new medical writers, offering direction, feedback, and support as needed.
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Their focus is cancer, understanding the science behind each potential cancer therapy and the challenges of moving therapies from mice to man.
Serves as a senior regulatory authority and trusted strategic partner to pharmaceutical and biotech C-suite executives, influencing enterprise-wide regulatory strategies.
Partners with the SVP & Practice Lead to shape the future direction of the Clinical & Regulatory practice, driving practice growth and translating regulatory landscape evolution into opportunities.
Proactively supports the practice's P&L, achieving annual revenue targets, leading pursuit strategies for high-value engagements, and setting delivery quality standards across the regulatory team.
Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner, it brings together strategy, evidence, engagement, and technology to engineer breakthrough value for clients in the healthcare sector.
Provide strategic advice regarding new product offerings, compliance, privacy, fiduciary obligations and state regulations on reproductive care.
Collaborate with cross-functional teams to identify and mitigate legal risk.
Carrot is a global fertility and family care platform supporting members and their families through life's moments. They are trusted by leading multinational employers, health plans, and health systems, delivering outcomes and experiences for members and cost-savings for employers.
Own clinical quality strategy for a rapidly scaling network spanning 20+ states, 400+ clinicians, and multiple care models.
Build clinical compliance policy infrastructure that anticipates growth rather than reacts to it.
Lead and develop a team that grows with the organization.
Cartwheel builds a new kind of mental health program for kids that puts schools at the center, supporting school staff. They are an early-stage company backed by top investors and looking for mission-driven teammates.
Collaborate closely with the Merchant Risk team to identify, assess, and mitigate compliance risks associated with merchant and platform partners.
Review and approve financial services marketing materials to ensure they comply with regulations and industry standards.
Work cross-functionally with departments such as Compliance, Legal, Risk, and Revenue to complete reviews and address compliance issues and their root causes.
Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest. They are a remote-first company, with a dedicated group of professionals committed to helping Affirm scale, innovate, and provide outstanding products.
Take incoming requests for appeals ensuring customer service and maximizing productivity.
Work with appeals team for multiple lines of business ensuring appeal submission for review.
Maintain quality standards, remain current on updated processes, and follow SOPs and HIPAA guidelines.
Judi Health is an enterprise health technology company providing a comprehensive suite of solutions for employers and health plans. They have full-service health benefit management solutions to employers, TPAs, and health plans.