Regulatory Affairs Specialist

4 days ago

Reading, Reading, United Kingdom Jobs in Science Full time

Job Summary:

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at Jobs in Science. As a Regulatory Life Cycle Manager, you will be responsible for building and maintaining medicinal product capability within our organization.

Key Responsibilities:

  • Build and maintain medicinal product capability within Regulatory Affairs Life Cycle Management.
  • Coordinate with local regulatory affairs for variations, renewals, and answering health authority requests.
  • Maintain global master dossiers and compile, review, and provide dossiers for local registration and compliance.
  • Advise the organization on potential regulatory risks and recommend compliant actions.
  • Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking system.
  • Ensure that the Veeva Regulatory Information Management system is maintained and updated for all activities under role responsibility.

Requirements:

  • Initial regulatory affairs experience (1-2 years), preferably in consumer health and preferably across multiple regulatory classification areas.
  • Strong motivation for dossier maintenance and product change management.
  • Skilled in working with complex regulatory databases.
  • Demonstrated ability to work independently in a matrix environment to build superior relationships with stakeholders.
  • Organizational skills and solution-oriented attitude to handle a complex product-country portfolio.

What We Offer:

  • A 12-month contract with a multinational consumer goods corporation.
  • The opportunity to work on a wide range of personal care and hygiene products.
  • A dynamic and matrix environment with a focus on building medicinal product capability.

Language: English (en-US)

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