The Start Up Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning. Will act as Subject Matter Expert for questions by other in-country members supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents.

In this role, you will manage all aspects related to Regulatory Affairs and Pharmacovigilance in connection with Expanded Access Programs (EAPs). This includes developing regulatory strategies, consulting clients, and managing complex projects to ensure EAPs are executed according to plan and in compliance with regulatory requirements and client expectations. Be a leader in a growing company.

PHIL is seeking a Compliance Manager to oversee pharmacy regulatory compliance, ensuring adherence to Board of Pharmacy regulations, HIPAA, CMS, PBM guidelines, and other regulatory requirements. This role will focus on license maintenance, compliance audits, regulatory reporting, and managing external inspections.

Immunovant is seeking a Senior Director, Clinical Quality Assurance (CQA) to serve as a key leader in Quality. This role involves leading Clinical Quality Assurance (CQA), ensuring compliance with global GCP regulations, and contributing to quality systems at a rapidly growing biotechnology company, ensuring patient safety.

Drive customer success with Veeva Regulatory Information Management (RIM) products in Europe, supporting software product management, specializing in Submissions, Submissions Archive and Publishing applications, advocating the voice of the customer, and shaping the product roadmap to support regulatory document management. You'll represent the Product organization in customer meetings and industry events and create valuable resources for both internal and external stakeholders.

The Regulatory Affairs Specialist will support frequent minor software releases and the EU MDR application. This role involves cross-functional collaboration for product changes, maintenance of documentation, and managing new product registrations. This individual will play a key role in HeartFlow regulatory activities for product changes.

This person will oversee and performs safety management activities with identification, triage and analysis of safety signals. The Sr. Director, Global Safety Management provides safety and department leadership to clinical development programs for Sponsors at RQM+.