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Senior CMC Regulatory Specialist

3 months ago

Uxbridge, United Kingdom Parexel Full time

When our values align, there's no limit to what we can achieve.

Are you a seasoned regulatory expert seeking a new challenge? We are currently in search of a skilled CMC Regulatory Manager (Regulatory Affairs Consultant) to contribute to our esteemed organization. This role is dedicated to a client project and offers flexibility for remote or office-based work across various European locations.

As the CMC Regulatory Manager, you will be instrumental in overseeing our global post-approval regulatory functions, with a specific emphasis on Chemistry, Manufacturing, and Controls (CMC) for biological products.

Key Responsibilities:

  • Formulate submission strategies and plans for post-approval CMC initiatives, including variations, renewals, market expansions, and annual reports.
  • Evaluate change controls and deliver regulatory assessments regarding quality modifications in production and quality assurance.
  • Examine study reports from quality control and production teams to guarantee adherence to regulatory standards.
  • Facilitate submission preparation in collaboration with various departments such as manufacturing, supply chain, quality control, quality assurance, and other regulatory entities.
  • Draft and/or review submission content to ensure compliance with regulatory standards, particularly concerning variations and inquiries from health authorities.
  • Oversee projects within all Regulatory Information Management systems, ensuring the upkeep of global submissions.
  • Identify, escalate, and mitigate risks linked to regulatory processes and activities.

Experience and Qualifications:

  • University-level education in Life Sciences or equivalent experience.
  • Prior experience in regulatory affairs, particularly related to technical/CMC/quality within the pharmaceutical sector.
  • Strong comprehension of CMC and post-approval regulatory standards.
  • Experience in drafting CMC (technical) sections of regulatory documents such as registration files or variations.
  • Knowledge of biological processes.
  • Background in validation/Quality Assurance/production within the pharmaceutical industry, with experience in preparing regulatory documentation and understanding qualification/validation principles.
  • Proficiency in Word, PowerPoint, Excel, and familiarity with Veeva Vault is advantageous.
  • Collaborative spirit, adaptability, accountability, and organizational capabilities.
  • Fluent in English (both written and spoken); proficiency in French, Italian, or German is a significant advantage.