A company is looking for an Associate Director, Regulatory Affairs and Submissions.Key ResponsibilitiesProvide regulatory guidance to sponsors regarding drug development and submission requirementsLead the preparation and submission of regulatory documents, including INDs and meeting requestsCollaborate with cross-functional teams to ensure high-quality submissions and compliance with regulationsRequired Qualifications and EducationMSc / MS or PhD in a relevant field5+ years of US regulatory experience in an industry settingStrong knowledge of drug development and regulatory policies, particularly ICH, FDA, and Health Canada guidelinesDemonstrated experience with leading IND submissions in the USExperience with Health Canada is an asset
Regulatory Affairs Senior Associate
A company is looking for a Regulatory Affairs Senior Associate to support regulatory document management and clinical trial submissions. ...
Associate Director, Global Regulatory Project Management and Strategic Planning
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI² TAU within our Global Regulatory Affairs organization, based remotely. How you will con...
Associate Director Regulatory Project Management
A company is looking for an Associate Director, Global Regulatory Project Management and Strategic Planning - GI. ...
Global Corporate Affairs Associate Director, Alzheimer’s disease
The Associate Director of Corporate Affairs (CA) for Alzheimer's disease will play a crucial role in supporting both the development and implementation of international strategies to improve the detection, diagnosis, and care of Alzheimer's disease. The candidate will report to the Executive Directo...
Director of Regulatory Affairs
A company is looking for a Director of Regulatory Affairs, Advertising/Promotion. ...
Program Manager, Biotechnology Masters Program
Under the leadership of the Program Director, the Program Manager will oversee the financial management of the Biotechnology Master's program and ensure the various initiatives are executed to plan and continue to build out the Program's offerings. The Program Manager of the Biotechnology Master's P...
Manager, Professional Standards
JobPosting","title":"Manager, Professional Standards","datePosted":"2024-10-18T00:00:00","validThrough":null,"description":"How You'll Make a Difference\nYou will be responsible for overseeing the development, maintenance, and accreditation of PMI's professional standards, including those related to...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
Compliance Specialist
Responsible for managing the corporate compliance calendar and preparing documents for corporate compliance filings. Coordinates and manages the corporate compliance calendar to help ensure timely compliance by responsible departments with required tasks. Responsible for the management of employee, ...
Design-Build Project Manager
The key focus of this position is to serve as the design team Project Manager (Design Manager) on design-build projects. This position is a senior engineering project manager position within the Transportation Business Line. Responsibilities include working closely with our contractor clients and pr...