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Regulatory Affairs Operation Specialist (limited) – Geneva

OM Pharma — Geneve
29.03. | Temporary | 100%

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.

29.03.2020
Employee, 100%

Contact

OM Pharma

Brice Muller

Phone: '+41 58 851 81 24

Fax: +41 58 851 80 03


Vifor Pharma

Flughofstrasse 61Glattbrugg

Industry

Biotechnology / Chemistry / Pharmaceutical

Vifor Pharma

Flughofstrasse 61Glattbrugg

Industry

Biotechnology / Chemistry / Pharmaceutical
Salary

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