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.
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.
Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.
Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.
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.
Hims & Hers is a health and wellness platform committed to better health by offering affordable and personalized care. As a public company traded on the NYSE, they are normalizing health & wellness challenges and innovating on their solutions to make better health outcomes easier to achieve.
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.
Provide technical and strategic leadership for late-stage CMC activities.
Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports.
Lead CMC meetings and ensure teams are aligned with overall CMC and program strategy.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. They aim to offer patients suffering from chronic skin diseases the greatest possible freedom from their condition. The company seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture.
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.
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.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
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.