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Regulatory Life Cycle Management Specialist

2 months ago

Reading, Reading, United Kingdom CK Group Full time

Job Title: Regulatory Life Cycle Management Scientist

Company: CK Group, a leading recruitment agency for the life sciences industry

Job Summary:

We are seeking a highly skilled Regulatory Life Cycle Management Scientist to join our client, a global consumer healthcare company, on a contract basis for 12 months. The successful candidate will be responsible for coordinating regulatory life cycle management activities across multiple countries, ensuring compliance with regulatory requirements and maintaining global master dossiers.

Key Responsibilities:

  • Coordinate regulatory life cycle management activities across multiple countries, including Europe and beyond.
  • Work closely with local regulatory affairs teams to ensure compliance with regulatory requirements.
  • Maintain global master dossiers and compile, review, and provide dossiers for local registration and compliance.
  • Ensure regulatory assessments are conducted for change controls in the Veeva Quality Tracking system.
  • Maintain and update the Veeva Regulatory Information Management system for all activities under the role's responsibility.
  • Provide strategic input into regional product labeling and approval to enable commercial activation of product launches.

Requirements:

  • Educated to at least Master's degree level in a relevant field, such as pharmacy, engineering, or chemistry.
  • Regulatory affairs experience in OTC medicinal products and experience of lifecycle management across EU or wider markets.
  • Experience of dossier maintenance and product change management, as well as working with complex regulatory databases.
  • Excellent attention to detail, good communication, and presentation skills.

What We Offer:

CK Group is a leading recruitment agency for the life sciences industry, and we offer a competitive salary and benefits package to the successful candidate.