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...
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 ...
Supports the Acquisition Program Manager (APM) in assessing what programs are within schedule and cost baselines. The NC3 Directorate's mission is to provide support to the Program Executive Office (PEO), the Deputy Director, Deputy AFPEO NC3, and staff for acquisition and administrative control of ...
Under the general direction of the Principal Investigator or designee, the Research Program Manager I is responsible for managing the day-to-day operations of NIH or other externally funded, large scale projects. The Research Program Manager will collaborate with investigators, consultants, project ...
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...
Cherry Hill Programs brings the magic to every experience by capturing moments that last a lifetime. In partnership with retail locations, tourist attractions and destinations across North America, Cherry Hill Programs contributes millions of holiday and souvenir experiences for children and familie...
Program Manager, Chemistry (Water Quality). Assists Program Manager, Water Quality Assurance and others regarding regulatory compliance and water quality, where applicable. Works under the basic supervision of the Senior Program Manager, Quality Assurance. Manages and maintains primary responsibilit...
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...
To meet Federal, State, and local Underground Storage Tank (UST) regulations, track and coordinate required UST system testing and inspections including any required regulatory agency follow-up to maintain compliance. Ensure electronic compliance records are maintained in Company platform and availa...
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...
Project Manager - Power Delivery. These consulting services provide clients with overall project management tasks in the areas of comprehensive engineering design of electrical transmission and distribution, substation, and transmission line projects nationwide. Project Manager Responsibilities:. Pr...
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...
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 ...
The Contracts and Compliance Specialist will be responsible for working closley with the logistics team to ensure documentation is in place for each supplier they're working with. ...
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...
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...
We have a robust pro Regulatory Affairs, Regulatory, Specialist, Principal, Product Development, Support, Business Services. ...
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. May lead small projects or represent Urology Regulatory Affairs on corporate teams, as needed. Regulatory Affairs or related experiences. Come join a g...
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 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. Represent Regulatory Affairs on cross-functional product development and manufact...