Key Responsibilities:Provide strategic and tactical regulatory guidance for in vitro diagnostics/companion diagnosticsDevelop regulatory strategies for product registration and study designsInteract with diagnostic partners and regulatory agencies for submissions and meetingsRequired Qualifications:...
The KYDA Partners team is seeking a Regulatory Affairs Manager to lead and manage the regulatory affairs department, ensuring compliance with regulatory standards and the quality management system. Support and collaborate with the New Product Realization Regulatory Affairs team. Support cross-functi...
Act as regulatory representative on product development teams, providing regulatory input to the PDE/project manager on all facets of regulatory compliance, including but not limited to predicate identification and comparison, verification and validation testing, risk management, standard and common...
Participate in or lead the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate. Regulatory Affairs within biotechnology/pharmaceutical industry. Support multiple Global Regulatory project...
This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This new team member will apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic thinking and creativity in support of programs. Develop...
Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities. Collaborate ...
Tallgrass Energy is currently in need of one Manager, Regulatory Affairs to join our Houston based Capital Projects Team. This role will report directly to the Vice President of Environmental & Regulatory, or other Leadership as assigned within the Capital Projects - Environmental & Regulato...
Experience acting as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This n...
Experience acting as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This n...
Associate Director, Regulatory Affairs Project Manager. Director, Regulatory Affairs and Program Management Team Lead. The Associate Director, Regulatory Affairs Project Management will be responsible for supporting the development and implementation of program strategy. The individual will be a key...
Perform comprehensive administrative and regulatory reviews of designated IRB submissions (which include biomedical, clinical trial, and social/behavioral science studies) by ensuring applications/submissions meet all federal agency regulatory requirements for human subject research;. ...
Act as regulatory representative on product development teams, providing regulatory input to the PDE/project manager on all facets of regulatory compliance. Regulatory Affairs Program Manager. With minimal direction from Director, Regulatory Affairs, this position is responsible for all activities r...
The Regulatory Affairs Manager is responsible for developing and maintaining the Company’s regulatory filings and submissions, as well as assisting with the overall Quality Management System. Under the supervision of the Director of Regulatory Affairs, author and maintain all Donor Center Registrati...
Closely monitor, analyse, develop regulatory priorities and coordinate positions and strategies for regulatory and market affairs in MISO and other priority markets. Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political...
Participate in or lead the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate. Regulatory Affairs within biotechnology/pharmaceutical industry. Support multiple Global Regulatory project...
Manager, Regulatory Affairs CMC will be responsible for contributing to CMC strategies as well as coordinating many aspects of CMC regulatory submissions. Reporting to the Head of Regulatory Affairs, the Sr. Initiate and/or contribute to local process improvements which have an impact on Regulatory ...
Closely monitor, analyse, develop regulatory priorities and coordinate positions and strategies for regulatory and market affairs in MISO and other priority markets. Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political...
Participate in or lead the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate. Regulatory Affairs within biotechnology/pharmaceutical industry. Support multiple Global Regulatory project...
HF Sinclair is seeking a Regulatory and Corporate Affairs Manager to support the Government Affairs and Corporate Management teams to further overall company objectives and identify regulatory and public policy trends. Assist Government Affairs, Legal, Operations, Commercial, and other internal team...
Act as regulatory representative on product development teams, providing regulatory input to the PDE/project manager on all facets of regulatory compliance, including but not limited to predicate identification and comparison, verification and validation testing, risk management, standard and common...
Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities. Collaborate ...
Manage a team of regulatory associates responsible for regulatory compliance and provide proper training and project delegation as needed. Review and approve claims, product labeling, marketing materials, and other relevant documentation to ensure compliance with regulatory requirements. Conduct reg...
The Product Safety & Regulatory Compliance Team is seeking a Regulatory Affairs Manager to join our team. Experience working in regulatory compliance, chemical control, regulatory affairs, environmental, laboratory or product safety in the agriculture industry. The Product Safety & Regulatory Compli...
Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities. Collaborate ...
HF Sinclair is seeking a Regulatory and Corporate Affairs Manager to support the Government Affairs and Corporate Management teams to further overall company objectives and identify regulatory and public policy trends. Assist Government Affairs, Legal, Operations, Commercial, and other internal team...