PAREXEL

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.

Bachelors Degree required preferably in life sciences or health-related discipline or equivalent experience.

Customer Strategy Senior Analyst in Access will be a vital member of the Customer Access Strategy team, enabling and supporting the development of proposals and account plans. The individual is highly motivated, able to work independently, and thrive in a dynamic fast-paced environment.

High level of expertise in the lifecycle management of radiopharmaceutical products, including CMC authoring, safety labelling experience, artworks annotations

Senior Medical device documentation Associate. Good understanding of the medical imaging devices compliance from a global and regional perspective, registration procedures, preparation of answers to questions from health authorities. PAREXEL

Experience and expertise in authoring, compiling and submission of country specific submissions (MAA,BLA, and post approval changes) of Biologics/Biosimilar products in various markets- Regulated (EU/US/Canada) and emerging markets. 

Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget.

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

An initiation Clinical Research Associate (iCRA) specializing in Pre SIV and Activation tasks will be assigned & accountable for managing and driving the strategy for the startup, Pre SIV and Activation tasks of the study. The iCRA also supports submission and approval process for the protocol amendments if applicable.