Interface with suppliers along with industry partners to ensure products and components meet regulatory compliance. Produce and maintain required compliance certificates, test reports to show conformance to regulatory requirements. Support regulatory compliance process improvement activities. Experi...
The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Job Description - IACUC Regulatory Compliance Specialist (3271795). Investigate and...
The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Investigate and document reports of non-compliance involving laboratory animal care...
The Regulatory Specialist implements and maintains assigned insurance data requirements for automated and manual programs to meet Enterprise and client management reporting requirements, insurance agencies, and insurance departments. You will report to the Manager, Business Compliance. You will lead...
Our client is currently seeking a Senior Regulatory Compliance Specialist. Monitor international standards and guide regulatory testing requirements. Support pre-compliance testing for new designs. Collaborate with third-party test houses for compliance testing. ...
Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. Can apply and adapt this understanding to projects to enhance probability of regula...
As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates acceptable skills with increasing independence ...
We are seeking a Project Manager to join our Boston office to manage select projects while developing and growing a group that is capable of executing large scale projects on a regional and national basis. The Project Manager is responsible for not only their projects but helping those around them. ...
You will also be responsible for establishing, monitoring and providing oversight or acting as a liaison for compliance programs, processes and department of insurance examinations, as well as making recommendations to leadership on compliance matters that affect the product portfolio, forms, system...
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 ...
This is a general application for compliance professionals in the life sciences sector. ...
The Supplier Quality Program Manager will lead all supplier assessments, performance management, and improvement programs. E Ink is seeking a Supplier Quality Program Manager who enjoys working in a fast-paced global environment, supporting manufacture of E ink’s innovative materials. Key roles and ...
Manager, Regulatory Affairs Labeling – Permanent – Georgia, North Carolina or Massachusetts. Proclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company with locations in Georgia, North Carolina and Massachusetts. The Manager, Regulatory Affairs Labeli...
The Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, an...
We are seeking a highly motivated and experienced Associate, Benefits and HR Compliance, (Compensation experience a+) to join our dynamic organization. The ideal candidate will have a strong background in benefits administration, data analysis, and compliance management, with specific experience in ...
The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. The Global Publishing Manager provides regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence i...
Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC. The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for exe...
Preferably as a manufacturing specialist, MSAT/PD, process engineering, or QA specialist. Arcadis DPS is looking for a Technical Operations Change Controls Specialist for a client in Boston, 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. Associate Director Regulatory Affairs. Responsible for integrating and applying knowledge of gl...
Full exposure to all facets of projects. ...
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 Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for commercial programs. Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. The ...
The Health and Safety Program Manager assists the Director of Clinical Operations in providing comprehensive leadership, programmatic management, and facilitation for assigned safety programs and initiatives as well as serving as an EHS subject matter expert. The Boston University Environmental Heal...
The Investment Oversight team is responsible for supporting investment compliance, including the monitoring of regulatory requirements and client-specific guidelines, trade oversight, and client reporting, as well as other specialized areas of compliance. Who we are looking forOfficer, North America...
Regulatory Affairs (RA) Specialist?. Regulatory Affairs (RA) Specialist who wants to grow your skills and take the lead on U. Plan and perform regulatory submissions, product registrations/listings and renewals towards FDA, Health Canada and other Regulatory Authorities. Coordinate and prepare respo...