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
Associate Director Scientific Affairs
A company is looking for an Associate Director, Scientific Affairs. ...
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...
Director of Compliance and Regulatory Affairs
A company is looking for a Director of Compliance and Regulatory Affairs (Payments). ...
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...
Associate Director Regulatory Project Management
A company is looking for an Associate Director, Global Regulatory Project Management and Strategic Planning - GI. ...
Senior Regulatory Affairs Specialist
A company is looking for a Senior Regulatory Affairs Specialist to manage the lifecycle of OEM products and ensure regulatory compliance. ...
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, ...
Senior Technical Project Manager
Project Manager - Senior Information Technology. Lead the preparation and delivery of complex Finance reports; manage project deliverables, milestones, and specified project tasks. Participates in meetings with business and/or project teams when appropriate to discuss projects, progress, and issues ...
System Integration Program Manager - New London, CT
Establish and maintain effective relationships with the program manager and the deputy program manager. Be the single point of contact on all contract management support related issues, including required reports and presentations to the program manager and deputy program manager, responsible for qu...
Materials Regulatory Compliance Specialist
The Materials Regulatory Compliance Specialist (MRCS) is responsible for ensuring compliance with applicable regulations, industry standards, and HPNE internal policies/procedures. Your responsibilities as a Materials Regulatory Compliance Specialist will include but not limited to:. Manage all proc...