ROCHE: PTR Junior Regulatory Associate (3 years contract)

At the Roche Group, about 80,000 people across 150 countries are pushing the frontiers of healthcare. Working together, we have become one of the world's leading research focused healthcare groups.

We look for:
Advanced student or degree in a relevant technical area (Analytical, Biochemistry, Biology, Pharmacy, Computer science).
Fluent in English is a must.
Proficient in the use of IT systems, data management, skills in automation a plus.
Proficient in Microsoft Office and Google Workspace.
Knowledge of Lean, Six Sigma, or Agile methodologies preferred.
Detailed oriented, able to manage repetitive tasks
Knowledge of ICH guidelines, GMP, global regulations and health authority guidance preferred.
At least 2-3 years of experience in the industry or related job experiences.
Experience in LEAN and Agile Methodologies preferred
Experience in Regulatory Affairs, development, manufacturing and/or quality assurance would be an asset.
Ability to travel according to the needs of the program.

Target position:
The heart of the role is the optimization, standardization and centralization of Pharma Technical Regulatory activities, ensuring increased efficiency while maintaining regulatory compliance.
In this position, you will be able to interact with different stakeholders from all over the world, working in close collaboration with cross-functional Global teams and Affiliates.
As soon as you start working, you will have the opportunity and responsibility to propose and execute specific process improvement projects, including standardization and automation of processes, in collaboration with other key functions, as applicable.
The candidate will interact with a diverse group of experts, in a competitive, motivating and dynamic work environment.
Your main activities can be described as follows:
-Execution of assigned CMC activities on a daily basis, you will do this in a systematic way so as to ensure the work is done with high efficiency and quality, while taking advantage of economies of scale
-You will be responsible to continuously evaluate the processes and provide input of potential improvements.
-Collaborate with the software developers to create new solutions.
-Learn how to execute and integrate new activities into your daily capacity, as further work transitions into the group.

This job posting is covered by Section 1 of Law # 19691 of labor promotion for persons with disabilities.