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Regulatory Affairs Manager

hace 2 meses

Alcobendas, Madrid, España Parexel A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory team, you will play a vital role in ensuring compliance with regulatory requirements for our clients.

Key Responsibilities
  • Develop and implement submission strategies for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from quality control and production departments to ensure compliance with regulatory requirements.
  • Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control, and quality assurance.
  • Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Manage projects within Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
  • Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
Requirements
  • University-level education in Life Sciences or equivalent by experience.
  • Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents, such as registration files or variations.
  • Knowledge of biological processes.
  • Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation.
  • Understanding of qualification/validation principles.
  • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
  • Team spirit, flexibility, accountability, and organizational skills.
  • Fluent in English (written and spoken). French, Italian, and German would be a strong plus.