This fellowship program invites applications from professionals with advanced degrees and strong backgrounds in science, health policy, and/or law, offering a perspective into regulatory science/policy, drug development, and market access. The fellow will gain knowledge of regulatory issues facing healthcare companies by researching, presenting, and publishing insights on regulatory topics.
An exciting new role with ICON's regulatory team working on high profile Pharma projects, the Regional CTA Submission Manager is accountable for leading operational submissions execution for designated CTAs, and operate as regulatory operational Subject Matter Expert for EU CTR. This role requires hands-on experience in Clinical trial applications under EU CTR.
Take a lead role in advancing medical research while guiding teams that make a meaningful difference in patients' lives. As the Associate Director of Clinical Monitoring, you will provide leadership and oversight for the clinical monitoring function, driving the implementation of strategies set by senior leadership. This role is responsible for developing and executing monitoring strategies, managing multiple clinical monitoring teams, and ensuring the highest quality standards.
You will be our in‑house ex‑reviewer who ensures each surgical dressings order is fully compliant with every CMS regulation, including regulation / policies as they are applied by MACs & UPICs. You'll translate LCDs/Articles and MAC playbooks into checklists, fix packet defects pre‑bill, and run our ADRs/appeals processes. Note that this role is an hourly, part-time engagement requiring ~10 hours per week.
An exciting new role with ICON within our regulatory team working on high profile Pharma projects. The Regional CTA Submission Manager (CTA-SM) is accountable for working with contributing to business lines to lead operational submissions execution for designated CTAs and may operate as regulatory operational Subject Matter Expert for EU CTR.
The Regulatory Affairs & Quality Manager maintains and improves certifications such as ISO 13485, as well as other relevant standards and regulations. They will oversee the Quality Management System (QMS), ensuring compliance and providing guidance, support, and training to the organization. The manager reports to senior management on the status of ISO systems and certifications.
Praxis's Regulatory team is seeking a Consultant for approximately 7-8 months, specifically a Senior Regulatory Submissions Manager to oversee the operational aspects of submissions to U.S. and international Regulatory Agencies. They will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of submissions in order to ensure the submissions are of the highest quality and delivered on-time.
The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements.