Regulatory Affairs Specialist

2 days ago

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

We are seeking a highly skilled CMC Regulatory Manager to join our 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 submission strategies and plans for post-approval CMC activities such as 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 the 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, and other regulatory departments and local companies.
  • Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Manage projects within all 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, preferably 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.

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