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24.03.2020

Regulatory Affairs Operation Specialist (limited) – Geneva

  • Switzerland - Meyrin/Geneva
  • Vollzeitstelle

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Regulatory Affairs Operation Specialist (limited) – Geneva

Location: Switzerland - Meyrin/Geneva
Function: Regulatory Affairs
Company: Vifor Pharma
Brice Muller
Talent Acquisition Consultant
+41 58 851 81 24
Apply
Agency policy
About you
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.
 
About us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals 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 has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

Apply
Agency policy

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.
Vifor Pharma
Regulatory Affairs

Arbeitsort:

Switzerland - Meyrin/Geneva

Brice Muller
Talent Acquisition Consultant
+41 58 851 81 24