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...
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 ...
Oversee multiple projects simultaneously to meet regulatory deadlines . UST compliance or project management experience. ...
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...
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...
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...
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...
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...
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...
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...
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 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...
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. Responsible for preparation and subm...
We have a robust pro Regulatory Affairs, Regulatory, Specialist, Principal, Product Development, Support, Business Services. ...
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...
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...
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 Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide. Senior Regulatory Affairs Specialist #24-150 | Posted 07/24/2024 Marlborough, Massachusetts Ap...
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...
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...