The Global RA Manager contributes to the Company's success by managing the Corporate R&D Pipeline (projects in R&D Development) by providing regulatory guidance to the R&D Global Core Team as well as other non-R&D functions, as needed. Accountable for global/regional regulatory strategies for new an...
The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration a...
Pharma and Personal Care – Regulatory Affairs Manager/ NA Regulatory Business Partner . Collaborate with global PPC and NA regulatory partners and Marketing & GTC teams to develop and execute regulatory intelligence programs that converts regulatory change information to actionable insights. Drive r...
At Thermo Fisher Scientific, the Regulatory Affairs function plays a vital role in ensuring compliance with the ever-evolving global regulations governing our industries. They collaborate closely with cross-functional teams, such as Research and Development, Quality Assurance, and Manufacturing, to ...
The Senior Manager, Regulatory Affairs is an experienced leadership position with a deep understanding of global regulatory requirements, a strong track record in navigating complex regulatory landscapes, and the ability to collaborate across cross-functional teams. The Senior Manager of Regulatory ...
Implement worldwide regulatory registration strategy, Communicate and negotiate with local market authorization holders/ distributors / regulatory authorities information required and prepares regulatory submissions to be used worldwide for all marketed products. Coordinate and interact with domesti...
Connections working at Duke University Health System https://regulatorycareers. ...
Regulatory Affairs Strategy and Management:. Manage and lead the preparation and review of US regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards. Regulatory Affairs Info...
The Global RA Manager contributes to the Company’s success by managing the Corporate R&D Pipeline (projects in R&D Development) by providing regulatory guidance to the R&D Global Core Team as well as other non-R&D functions, as needed. Accountable for global/regional regulatory strat...
The Senior Maintenance Project Manager is responsible for oversight of complex projects to include development, implementation, coordination, schedule, budget, documentation, turnover, and compliance of construction, renovation, upgrade, replacement, and repairs involving buildings, grounds, facilit...
We are currently looking for a Technical Project and Program Manager, Broadband Grants to join our growing team! In this role, you will report to the Vice President Regulatory, Compliance and Broadband Office, as we work to attract hundreds of millions of dollars in state and federal grants to Brigh...
Facilities Infrastructure Project Manager. Assist with overall project documentation and reporting including electronic documentation management systems and project management software. Provides leadership as the designated representative at project meetings through all phases of the project. Apply ...
Provides project management duties for assigned capital and non-capital projects to include: procurement of professional design services, overseeing design team during design phases, project scheduling, project budget, pre-qualification of contractors, solicitation of contractor bids, contractor sel...
The Project Manager Client Delivery will serve as the bridge between our clients, internal teams, and partners to manage the operational execution of projects. Manages project team members with regard to assigned tasks on those projects - team members are matrixed in for project assignments. The Pro...
EisnerAmper is looking to hire a Senior Manager to join its Risk and Compliance Services practice as a dedicated member of the National Security Advisory services team. The Risk and Compliance Services National Security team drives value by delivering a range of risk advisory and compliance solution...
Are you ready to take on a pivotal leadership role in the dynamic world of warehouse operations? As our Warehouse Operations Manager, you'll be at the forefront of optimizing all aspects of warehouse operations, from facility management to team leadership. At Alta, we go beyond mere service provisi...
This position is specific to the Healthy Opportunities Pilot Program. The Care Manager may work remotely within regions to cover the needs across the state. Refer to appropriate clinical team members for interventions which are outside the Care Managers’ scope of practice and/or expertise. ...
Looking for a Regulatory Affairs Specialist with at least 2 years of regulatory experience along with submissions. Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Primary or secondary contact person for ethics committees and regulatory authorities, ...
Senior Regulatory Affairs Specialist. A leading global medical device company is looking for a motivated and experienced individual to join their team as a Senior Regulatory Affairs Specialist at their facility in the greater Charlotte area. The Senior Regulatory Affairs Specialist will be responsib...
The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval. In collaboration with the V...
The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environment...
The Director / Associate Director of Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment and in compliance with local and regional requirements, and company policies. This role...
This job is responsible for supporting the successful implementation of the requirements of the Global Compliance - Enterprise Policy, the Operational Risk Management - Enterprise Policy (collectively "the Policies") and the Compliance and Operational Risk Management Program through partne...
JOB TITLE: Associate Program Manager. Financial advisors may be located within or at an outside managed program. Develop and implement a Financial Advisor development program, including continuing education and professional development resources. ...
Risk and Compliance Operational Enterprise Risk Manager. Protiviti is looking for a Risk and Compliance Manager to join our growing Operational Enterprise Risk team. As a Manager, you'll partner with our clients to solve complex business problems and provide impactful advice and solutions. Collabora...