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Regulatory Life Cycle Manager Medicinal Products Specialist

2 months 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 Medicinal Products, 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 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 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 dynamic and supportive work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package