Job type: Contractor Employee (7 months)
Schedule: Full-time - hybrid modality
Location: Montevideo
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. We are looking for a proactive, curious, eager to learn candidate, with a mindset focused on increasing productivity of work, ready to join a multicultural team. The candidate will interact with a diverse group of experts, in a competitive, motivating and dynamic work environment.
Primary duties of this position
- 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.
Education
- Advanced student or degree in a relevant technical area (Analytical, Biochemistry, Biology, Pharmacy, Computer science).
Experience
- 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
Knowledge/Skills/Competencies
- Fluent in written and oral English (Exclusive)
- Strong communication skills
- Detailed oriented, able to manage repetitive tasks
- Proficient in the use of IT systems, data management, skills in automation a plus
- Proficient in Microsoft Office and Google Workspace.
- Ability to work across various time zones
- Critical thinking and problem solving skills, will be appreciated
- Optimization and simplification mindset. Knowledge of Lean, Six Sigma, or Agile methodologies preferred.
- Knowledge of ICH guidelines, GMP, global regulations and health authority guidance preferred
Travel Requeriments
- Ability to travel according to the needs of the program
