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Viatris

Global pharma selling generics and biosimilars

Associate Manager - Rim Data Maintenance

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeLisbon, PortugalNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree or equivalent is required.
  • A minimum of 5 years of pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations, or another relevant field is required.
  • The candidate must be able to understand complex IT tools and software.
  • Experience with the Veeva Regulatory Information Management system and eCTD backbone structure is required.
  • The candidate must be able to multitask and manage multiple projects and deadlines.
  • The candidate must be able to work in a global, highly cross-functional team environment.
  • The candidate must have high attention to detail.
  • The candidate must have written and verbal communication skills.
  • The candidate must be proficient with Microsoft Office tools, including Excel, PowerPoint, and Word.

Responsibilities

  • Manage a data maintenance team supporting the Veeva Regulatory Information Management system.
  • Partner with Regulatory teams to create and revise records, objects, and activities in the Regulatory Information Management system for a large, global portfolio of pharmaceutical products.
  • Verify that accurate and up-to-date regulatory information on globally submitted or notified products is entered into the RIM system and available to stakeholders.
  • Collaborate with the Regulatory Affairs team to address queries related to RIM data entry.
  • Propose improvements to the RIM system, processes, and procedures.
  • Participate in IT and cross-functional initiatives, including new systems, system enhancements, and integration activities, to assess their potential impact on Master Data Management, Data Quality, and Regulatory Compliance.
  • Participate in data transformation projects by proposing mapping rules and analyzing and validating data.
  • Identify and implement continuous improvement initiatives based on data analytics.
  • Provide support for data queries from business units and escalate them to the support team as needed.
  • Assist with training RIM Data Maintenance Specialists in data entry, system workflows, and navigation of submission backbones.
  • Contribute to developing and implementing departmental Standard Operating Procedures, user manuals, and data standards consistent with industry best practices.
  • Perform other duties as assigned.

Desired Qualifications

  • Project management experience is preferred.

About the Company

Viatris

Global pharma selling generics and biosimilars

Viatris is a global pharmaceutical company that provides access to medicines through a diverse portfolio of branded drugs, generics, complex generics, and biosimilars, serving patients in more than 165 countries. Medicines are produced and distributed via Viatris's extensive global supply chain and commercial network, making therapies available across cardiovascular, infectious diseases, immunology, and oncology. The company differentiates itself with a large, diversified product mix, broad international reach, and a focus on access and public health rooted in the Mylan-Upjohn lineage. Its strategy combines organic growth with partnerships and acquisitions to expand patient access while pursuing sustainable operations.

Company size
10,001+
Company stage
IPO
Headquarters
Canonsburg, PA
Founded
1961

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