Lead research governance and compliance processes for biomedical research programs, ensuring ethical and regulatory adherence.
Design data governance frameworks for sharing sensitive human data, balancing access with responsible stewardship.
Collaborate with scientific communities and institutional partners to implement governance systems that protect participant rights and research integrity.
Sage Bionetworks architects a more open, equitable, and data-driven scientific ecosystem by democratizing information and breaking down disciplinary barriers to accelerate research. Founded in 2009, this high-agility nonprofit fosters a culture of curiosity, innovation, and diverse perspectives, operating at the intersection of science, technology, and ethical data sharing.
Provides regulatory CMC support for drug-device combination products.
Reviews submission documentation and contributes to global regulatory strategies.
Collaborates with cross-functional teams including device development, quality, and clinical.
Vertex Pharmaceuticals is a global biotechnology company dedicated to developing transformative medicines for serious diseases. With thousands of employees, it fosters a collaborative and innovative culture focused on patient impact.
Lead pharmacovigilance strategy and operations across the portfolio, ensuring regulatory compliance and safety oversight.
Oversee outsourced PV vendors, build quality systems, and manage safety data exchange agreements.
Partner cross-functionally with Clinical Development, Regulatory, and Quality to advance pipeline from early to late-stage development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a lean organization with a build-oriented culture, advancing a pipeline from Phase 1 to Phase 3.
Lead operational and lifecycle management of Regulatory CMC submissions for cell therapy programs.
Develop and execute global regulatory CMC strategies aligning with program objectives.
Serve as Regulatory CMC lead on cross-functional teams, providing strategic guidance.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. It operates as a small, mission-driven company in a fast-paced environment.
Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements.
Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables.
Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.
Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.
Lead scientific validation and regulatory qualification strategies to accelerate adoption of Advanced Cell Models solutions.
Drive U.S. regulatory acceptance activities including FDA ISTAND Pilot Program and DDT qualification pathways.
Build scientific collaborations with key opinion leaders and academic institutions to strengthen external scientific credibility.
Sartorius accelerates the development and production of innovative therapies for better health. As a global life science company listed on the German DAX and TecDAX, they offer a wide range of benefits and a welcoming culture.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Lead complex hospital and professional billing compliance audits and investigations to identify risks and ensure regulatory alignment.
Analyze billing, coding, and operational data to uncover systemic issues and provide actionable recommendations to leadership.
Serve as a billing compliance subject matter expert, advising cross-functional teams and developing training and policies.
The company is a healthcare organization focused on billing compliance and risk management, providing auditing and advisory services. It offers a remote-first collaborative environment with opportunities to influence policies and work with senior leaders.
Manage reprocessing and infection control activities for the endoscopic product portfolio, serving as the primary company resource and subject matter expert.
Work cross-functionally with customers, third-party companies, and internal stakeholders to ensure reprocessing recommendations satisfy US market needs and comply with industry guidelines.
Develop validation programs, technical manuals, and educational tools while representing the company on national committees and keeping leadership informed of trends.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and is guided by a Group Purpose of giving our world more smiles, offering a dynamic and flexible work environment.