Senior Regulatory Compliance Officer

4 days ago


London, Greater London, United Kingdom Clinical Professionals Limited Full time

Job Overview:

We are seeking a Senior Regulatory Compliance Officer to join our team in Central London / West End. As the lead GCP Subject Matter Expert (SME) on the development team, you will ensure regulatory and quality compliance with GCP standards and other relevant regulatory requirements.

Responsibilities:

  • Act as GCP and EMEA regulation SME, contributing to a risk-based, scientifically-driven quality system for supporting GCP compliance.
  • Lead the assessment and approval of vendors for potential use, offering guidance and oversight to ensure alignment with company quality and compliance standards.
  • Collaborate cross-functionally to address and mitigate GCP quality and compliance issues.
  • Ensure adherence to the ICH E6 Guideline for Good Clinical Practice and mentor staff to enhance quality and auditing skills.
  • Manage quality documentation in Veeva QMS and Vault.
  • Represent the company in regulatory inspections.

Qualifications:

A BS in Biology, Chemistry, or related life sciences degree with at least 7-10 years of experience, or advanced degree (MS, PhD, MBA) preferred with additional equivalent experience. Experience with managing regulatory inspections, collaborating with regulators and internal staff for inspection preparation, SOP development relevant to clinical, regulatory and medical processes, proficiency in GCP and EU clinical regulations, and risk-based quality systems aligned with ICH E6.

Salary: £80,000 - £110,000 per annum, depending on experience.

Travel Requirements: Able to travel domestically and internationally (25-30%).



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