Regulatory Affairs Infrastructure Submission Management

Ort: Switzerland - Glattbrugg/Zurich

Medha Khanna

Senior Talent Acquisition Manager

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Regulatory Affairs Infrastructure Submission Management

Vifor Pharma is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. Due to this we are looking to expand the Regulatory Infrastructure group with an additional hire within the team.

This position will focus on supporting the regulatory group with high class submissions publishing, system lifecycle/implementation and excellence and regulatory information management. You will have a background in regulatory operations, submissions publishing and or RIM. This position will be based at our global HQ in Glattbrugg, Switzerland.

Responsibilities

  • Planning, coordination, publishing, archiving and ensuring high quality, “Right First Time” dossiers
  • Collaborate with Global Regulatory Teams to develop and maintain submission content plans
  • Manage system upgrades/updates to ensure health authority requirements and compliance standards are met
  • Serve as Project Manager Business of the publishing tool
  • Work closely with global stakeholders and IT to define requirements, evaluate technologies, implement operational solutions for new systems and interfaces and related processes to meet the evolving business and regulatory environment
  • Serve as an administrator to country specific portals and gateways e.g. EMA, MHRA, and Swissmedic
  • Review and analyse internal technologies and processes, identify inconsistencies and lead activities to be in line with the company business objectives, standard procedures and policies, regulatory authority requirements and partner company agreements
  • Be an expert in current and upcoming publishing standards, procedures, and data specifications in Europe

Key Measures of Success in the role

  • Quality of planning, information and inputs provided to the stakeholders and projects
  • Delivery of on-time and accurate dossier documentation and health authority submissions
  • Effectiveness of collaboration with relevant functions and teams
  • Optimal operational support for GRA and other relevant stakeholders
  • Understanding and compliance with relevant health authority regulations, guidance and procedural requirements
  • Vifor’s ability to meet changing external standards and technical requirements in the area of Regulatory Affairs Infrastructure

Qualifications & Experience required

Minimum Requirements

  • At least 3 years of experience in the pharmaceutical industry in a relevant area
  • At least 3 years of experience  building and validating successful various EMA, and other regions, eCTD submissions
  • Knowledge of eCTD standards including document rendering, electronic submission publishing, and validation and using Regulatory Information Management tools
  • Experience in system and database implementations
  • Demonstrated strong expertise in project management in relation to development of content plans, managing submission documents through work streams, and overall coordination of submission activities
  • Excellent Microsoft Office and Adobe Acrobat skills
  • Experience of planning and compiling submissions for CH, EU, US and ROW
  • Fluent in English

Preferred Requirements

  • Good command of German (written and spoken)
  • Records management experience
  • Publisher with experience of using docuBridge
  • Experience of using PDF tools such as DXC toolbox
  • xEVMPD/ IDMP data management experience
  • Knowledge of Software Development Life Cycle methodologies preferred
  • Ability to lead, manage, and contribute to multiple ongoing projects simultaneously and contribute to improvement initiatives
  • Familiarity with document requirements of ICH/GCP and other regulatory guidance’s appropriate for the preparation of dossiers
  • A good understanding of emerging global regulatory requirements
  • Familiarity with document requirements of ICH/GCP and other regulatory guidance’s appropriate for the preparation of dossiers

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