Regulatory Affairs Operation Specialist (limited) – Geneva
We are currently looking for an experienced Regulatory Affairs Operations Specialist to support our team in Geneva for a period of 9 months. In this function, you report to the Regulatory Center of Excellence Team Lead and your responsibilities include the following tasks:
- Collect documents for submissions, ensuring compliance and, formatting
- Compile, publish and dispatch electronic and paper submissions to meet health authority requirements
- Interact with internal departments to ensure timely submissions and to support global filings
- Achieve business objectives and priorities within Regulatory Operations with a specific focus on electronic document management, electronic regulatory submissions, submission tracking and other electronic systems used by GRA
- Maintain and coordinate updates and problem solving issues related to publishing software
- Organize access to electronic Gateways to enable submissions being uploaded to Health Authorities
- Work closely within a team in a globally focused environment to achieve team and company goals
- Manage the regulatory documentation in accordance with regulations, in-house SOPs, workflows and systems.
- Contribute to the continuous improvement of workflows and systems.
For this role, we are looking for a highly motivated and organized person bringing the following profile:
- At least 3 years’ experience in the preparation of electronic Regulatory submissions in the pharmaceutical industry.
- Knowledge of eCTD publishing systems (docuBridge experience an advantage), electronic document management systems and Regulatory tracking software
- Experience of planning and compiling submissions for CH, EU, US and ROW
- Fluent in French and in English
You can navigate organizational complexity through teamwork, clearly structured data enquiries and effective communication. You feel comfortable in a role where you can collaborate, negotiate and influence others thanks to your technical expertise and your analysis of the future regulatory implications and impacts.