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...
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...
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...
Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Manage and maintain regulatory databases and technical files. Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency req...
We are seeking an experienced leader with proven management and regulatory expertise s related to. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and ma...
The project manager will work with other critical facilities specialists to evaluate new and existing server room and other critical environment projects. Project Manager – Critical Facilities Design Build – Marlborough, MA. Their projects are in the design-build areas for Cleanroom Cons...
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...
Milton CAT is looking for an IT Project Manager based in Milford, MA that combines technical expertise with project management skills. As an IT Project Manager you will manage multiple medium to large sized projects concurrently using industry standards and best practices from requirements gathering...
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...
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 Operational ...
We take pride in offering comprehensive support to our project managers, empowering you to focus your efforts on the seamless execution of solar projects. We specialize in commercial and industrial electrical contracting services, bringing over 20 years of experience to every project. Our unwavering...
We are seeking a Regulatory Affairs Specialist to assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations. Develop and implement regulatory strategies for new and existing products. Suppor...
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...
As an Internal Controls Advisory & Compliance Manager, you will manage compliance testing, risk and control assessments and documentation for the TJX Sarbanes-Oxley (SOX) Office, and other compliance programs, as needed. Internal Controls Advisory & Compliance Manager. You will collaborate with memb...
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. Responsible for preparation and subm...
The Associate Director/Director Biologics CMC Regulatory Affairs will play a key role in the progression of Biologics pipeline candidates by providing regulatory affairs related oversight of key CMC development and manufacturing efforts that are currently ongoing both internally and externally throu...
The Principal Compliance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. Principal Compliance Specialist. Your job, as Principal Compliance Specialist on our Quality Assurance (QA) Operations team, wi...
CRJ wants you to join our growing team of compassionate and dependable Program Managers to support the wonderful individuals we serve!. Ensure that personal, medical and nursing care, behavior plans, teaching programs and other services are delivered by program staff in an appropriate and consistent...