PAREXEL

Lead end-to-end Clinical Trial Application submissions globally, managing projects and timelines. Requires a Bachelor degree in Life Sciences/Pharmacy, work remotely, 5 years industry experience, and proven expertise in EU CTR and ROW CTA submissions, project management, and regulatory processes.

As a Patient Safety Associate II/Specialist, you will support global pharmacovigilance activities that advance new treatments for patients. This position plays a key role in safety case processing, regulatory submissions, literature surveillance, and compliance with international regulations.

Triage and manage Requests for Information (RFI) from regulatory authorities, coordinating responses with relevant stakeholders. Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and ensure compliance with country requirements

Responsible for one or several of the following: processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information

Seeking an Initiation Clinical Research Associate II (Site Start Up EUCTR II) to join our team in a Hybrid capacity at our Hyderabad office. As an Initiation Clinical Research Associate II, you will support complex clinical trial initiation activities that advance new treatments for patients.

Responsible for following the best practices regarding - processes, communication (internal & external), project management, and documentation

Support global regulatory lifecycle management activities across EU, US, and international markets. Contribute to regulatory strategy development for global and regional submissions

A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides.

This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.