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.
Vifor Pharma Group, formerly Galenica Group, is a global pharmaceutical company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions.The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma. With its unique expertise in the field of immunology, OM Pharma develops and manufactures infectious diseases/OTX products for respiratory tract infections, lower urinary tract infections, ear care, abdominal distension, chronic obstructive pulmonary disease, chronic venous insufficiency, diabetic retinopathy, haemorrhoids, menometrorrhagia (heavy menstrual bleeding).
Location: Switzerland – Meyrin/Geneva
Function: Regulatory Affairs
Company: OM Pharma
Seniority Level: Specialist
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