Works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations.
The Principal is responsible for the delivery of service offerings and ensures the delivery of regulatory and quality solutions that are best practice and innovative to enable client success through the delivery of superior service. This role involves leading the delivery of regulatory and quality solutions, directing and advising others in the development of work products, and executing the defined consulting scope of work.
Contribute to the development and implementation of regulatory strategies aligned with corporate goals and timelines. Assist in planning and coordinating regulatory submissions and interactions with health authorities. Prepare, review, compile, and archive regulatory documents, including IND applications, Biologics License Applications (BLA), Regenerative Medicine Advanced Therapy (RMAT) designations, and Marketing Authorization Applications (MAAs).
The Clinical Trial Manager is a leadership role responsible for driving the successful execution of protocols or projects, including decentralized trials, from strategic planning through close out. This involves managing timelines, budget, SOPs, and regulatory requirements to operationalize trials across the organization and site network within Care Access Research.
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities.
Shall be responsible for the ongoing development and updating of the MedTrainer knowledge base including; linking regulatory requirements, accreditation standards, federal and state mandates, and related compliance best practices to MedTrainer products and solutions. The position is responsible for the creation and adaptation of healthcare policies, compliance checklists, competency assessments, guidance, and other related compliance resources for deployment in the MedTrainer Compliance Library.
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.
This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences, and includes aligning DSS study teams with program- and study-level strategies. For assigned programs and studies, the role leads the DSS Study Team and represents DS as a member of the cross-functional study team. The role also utilizes operational analytics and project management tools to optimize execution of programs and studies.
The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. He/she will contribute to strategic planning for the department and manage assigned projects. He/she will also network and benchmark outside of AbbVie to provide for best practices and processes.
Caribou Biosciences is seeking a Clinical Trial Manager to join our growing Clinical Operations group, responsible for the execution and oversight of clinical trials from start-up through close-out, ensuring alignment with ICH-GCP, applicable regulations, internal SOPs, and protocols. The CTM will collaborate cross-functionally, manage vendors and sites, and contribute to high-quality clinical trial delivery.