Senior Regulatory Affairs Associate. Assessment of the Change Controls and associated technical dossiers. ...
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across diff...
We are recruiting for a French Speaking Senior Regulatory Affairs Associate in Europe. Senior Regulatory Affairs Associate- CTA. Previous CRO / Pharma experience working in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant with CTA submission knowledge is essent...
The Associate Manager, Regulatory Filings will assist firms seeking to register as an SEC or state registered investment adviser with the registration process. This role will also be responsible for preparing and submitting regulatory filings on behalf of the company’s investment advisory clie...
As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. ...
The Associate Director – CMC Regulatory is responsible for leading global CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC regulatory impact of change ...
The Regulatory Strategy Lead works to coordinate interactions with FDA and other Health Authorities, to validate regulatory strategy, and to facilitate planning of regulatory agency meetings and interactions. The Regulatory Strategy Lead will also be responsible for recommending strategies for earli...
This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Reporting t...
The Regulatory Strategy Lead works to coordinate interactions with FDA and other Health Authorities, to validate regulatory strategy, and to facilitate planning of regulatory agency meetings and interactions. The Regulatory Strategy Lead will also be responsible for recommending strategies for earli...
As a Regulatory Compliance and Operational Risk Senior Associate, you will get the opportunity to grow and contribute to our clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Risk Advisory Practice – all ...
Drives the CMC strategy for camlipixant or similar products coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standard...
Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexingt...
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. This goal must be achieved both as a component of an overall glo...
RSM's AML/Regulatory Compliance group is currently seeking a strong resource to join our fast growing Risk Consulting practice at the Senior Associate level. This position will lead and deliver regulatory compliance internal audits, assessments, model validations and other services at client locatio...
She/he utilizes in-depth knowledge of global regulatory submission requirements and works collaboratively within Regulatory Affairs and other cross-functional departments in providing guidance towards achieving department application filing objectives, identifying areas of concern that are impacting...
Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issu...
Provides daily operations management of research projects working in collaboration with the Principal Investigator and project teams; supervises staff, plans meetings and manages budget. Oversee day-to-day research project management, coordinate the activities of each research project and support te...
Director of Regulatory Affairs, Academic Affairs Office, Penn Law. Director of Regulatory Affairs, Academic Affairs Office, Penn Law. The Director of Regulatory Affairs serves as the point person for all regulatory issues related to the University of Pennsylvania Carey Law School's program of educat...
The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes. Regulatory Affairs Program Manag...
Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulat...
The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and w...
The Regulatory Affairs Manager works within a team environment or individually based on the project needs, such as:. Interested candidates in the Regulatory Line Manager from Mexico, DC (at least 3 or 4 years of experience) leading large teams. The Manager within R&A provides leadership and directio...
Ansible Government Solutions, LLC (Ansible) is seeking a full-time Compliance & Credentialing Specialist. This work-from-home position is responsible for carrying out various day-to-day responsibilities that support the team with credentialing and compliance initiatives. Coordinates and reviews ...
We are seeking a detail-oriented and proactive Special Projects Manager 1 to assist in the management and execution of designated operational tasks and projects. This entry-level position supports the Special Projects Manager and works closely with various teams including the COTR, Clinical Council,...