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Regulatory Affairs Specialist

2 months ago

Uxbridge, United Kingdom Parexel Full time
CMC Regulatory Manager Job Description

We are seeking a highly skilled CMC Regulatory Manager to join our dynamic team at Parexel. As a key member of our regulatory affairs team, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.

Key Responsibilities:
  • Develop Regulatory Strategies: Create submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
  • Regulatory Assessments: Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Submission Preparation: Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
  • Content Creation: Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Project Management: Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
  • Risk Management: Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
Requirements:
  • Education: University-level education, preferably in Life Sciences, or equivalent by experience.
  • Experience: Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Knowledge: Strong understanding of CMC and post-approval regulatory requirements.
  • Skills: 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.
  • Language: Proficiency in English (written and spoken). French, Italian, and German would be a strong plus.