Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Collaborates with other functional work teams , Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of glob...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
Provide program level acquisition support to the Program Manager and Integrated Product Team Leads by helping guide successful program execution to maintain the acquisition battle rhythm and deliver warfighter capability. Provide support and solutions to program leadership to facilitate successful c...
The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. Conceive of and Implement the Regulatory Strategy in ...
The Ethics & Compliance Manager Position reports directly to the Ethics and Compliance Director, who reports to the VP of Enterprise Risk Management & Compliance (including Data Privacy and Protection). This individual will support the development, implementation, and maintenance of the Oper...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
The ideal candidate for the Network Manager role at Paragus is a tech-savvy pro with a strong grip on network management, security, and compliance. We’re looking for a dynamic and experienced Network Manager who’s serious about growing their IT career and making a real impact. From monit...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Responsible for integrating and applying knowledge of global regulations governing radiopharmac...
Serve as project manager on projects & project phases. Code Red Consultants is seeking an experienced Senior Project Manager to manage projects and client/AHJ relationships and provide professional assistance on complex fire and life safety issues through code consulting, fire protection design,...
We are seeking an experienced leader with proven management and regulatory expertise s related to advertising/promotional materials and labeling. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness c...
This individual will own the internal audit program, inspection readiness and external audits / inspections, Compliance Surveillance, Quality metrics, Quality Management Review (QMR), and other compliance activities as assigned. Plans and executes compliance audits of internal operations as they rel...
Marketing Collabs Program Manager Co-op. Maintain program tracker and prepare different views as well as assist in developing project plan template that can be used to create program schedules with key milestones. Support a system to accurately track budgets for all programs. Assist in leading and m...
The Global Trade Compliance team is responsible for ensuring companies compliance with global Customs authorities as well as facilitating compliance in all day-to-day activities undertaken by the Company. The Operational Trade Compliance Analyst will be responsible for supporting in daily operationa...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Responsible for integrating and applying knowledge of global regulations governing radiopharmac...
Responsibilities for preparation and submission of global regulatory applications, as well as maintenance of internal regulatory file documentation. Come join a growing, global division and become a member of a large and experienced regulatory team!. Acting as company representative, developing and ...
We are seeking a highly collaborative, proactive Customs & Trade Compliance Analyst to ensure our adherence to U. Manage and conduct import and export compliance audits, review corrective actions, evaluate broker/freight forwarder compliance and report monthly metrics. Identify and report to Bose Co...
Principal Regulatory Affairs Specialist - Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Acts as a core team member on develo...
Responsibilities: A Program Manager overseeing the implementation of a grant focused on refugee and immigrant maternity care would have a variety of responsibilities to ensure the program's success. A Program Manager overseeing the implementation of a grant focused on refugee and immigrant maternity...
We have a robust pro Regulatory Affairs, Regulatory, Specialist, Principal, Product Development, Support, Business Services. ...
Credence Management Solutions, LLC (Credence) is seeking a Program Manager in support of the Cyber Resiliency Office for Weapon Systems (CROWS) at Hanscom Air Force Base, Massachusetts. Assist with DoD and DAF program/project analysis including the planning and organizing of program/project activiti...
Principal Regulatory Affairs Specialist – Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Acts as a core team member on develo...
We are seeking an experienced leader with proven management and regulatory expertise related to advertising/promotional materials and labeling. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness com...