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Data Driven Regulatory Professional

Data Driven Regulatory Professional

beBeeRegulatoryMadrid, Comunidad de Madrid, España
Hace 22 días
Descripción del trabajo

Overview

We are seeking a skilled Regulatory Information Associate to join our team. This role involves managing and overseeing Product Regulatory Information, ensuring its integrity with business processes and regulations worldwide.

The successful candidate will report directly to the Associate Director, Regulatory Operations & Systems Management.

Responsibilities

  • Develop and implement standardized data management strategies, processes, and tools.
  • Collaborate with key stakeholders to gather data requirements and contribute to the definition of data principles that address business needs.
  • Provide guidance on data architecture aspects such as data modeling, database design, and integration processes.
  • Support the management of Product Regulatory Data to maintain data integrity and ensure compliance with IDMP standards.
  • Perform Data Entry tasks within the RIM System, accurately and efficiently.
  • Promote a data-driven culture by providing education and guidance on data best practices and ensuring adherence across the organisation.
  • Assist in conducting Data Quality Checks and Data Analysis to ensure that data quality standards are met.

Requirements

  • Education : Bachelor's degree in computer science or technology or Health Sciences (e.g., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent.
  • Languages : Fluent English required (oral and written); knowledge of Spanish and other languages will be an asset.
  • Experience : 3 to 5 years' experience in regulatory or regulatory operations in the biotech or pharmaceutical industry.
  • Specific Knowledge : In the RIM System on Data entry and Maintenance of Approved Product Information details and on the management of Documents and Dossiers; In the preparation, publishing, and eCTD submission for IND / CTA, BLA / MAA to regulatory agencies, including interactions with Health Authorities and lifecycle management of eCTD submissions.

    • What We Offer

  • Flexible start time from Monday to Friday (full-time).
  • Permanent contract.
  • Attractive salary package.

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    Data Professional • Madrid, Comunidad de Madrid, España