Regulatory Compliance Specialist
Green Life Science
We are seeking a Regulatory Compliance Specialist to support international biospecimen procurement and biobanking operations, ensuring ethical sourcing, regulatory compliance and robust quality standards across a global vendor network. Key Responsibilities Monitor international regulations governing human biological materials, biobanking and cross border transport. Conduct remote vendor audits, compliance reviews and supplier qualification. Review vendor licences, accreditations, informed consent forms and IRB/IEC approvals. Assess regulatory and ethical risks associated with biospecimen sourcing. Develop, review and maintain SOPs, compliance checklists and quality documentation. Support eQMS/document control and CAPA tracking. Requirements Bachelor’s or Master’s degree in Life Sciences, Biotechnology or a related discipline. 5+ years’ experience in Regulatory Affairs, QA or Compliance within biotech, pharma, CRO or biobanking. Knowledge of GCP/GCLP, ISO 20387, GDPR/HIPAA and human sample ethics. Experience with vendor audits, informed consent documentation and SOP development. Familiarity with eQMS platforms; Cognidox experience is an advantage. Excellent written and spoken English, strong attention to detail and independent working skills. What’s Offered Fully remote working. Competitive compensation. Collaboration with an international team supporting biomedical research and diagnostics. #J-18808-Ljbffr Green Life Science
Vacancy posted 4 days ago
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