Industry: Biotechnology / Biobanking / Biospecimen Procurement & Human Biological Materials (HBM)
Department: Regulatory Affairs & Quality Assurance
Location: Remote
Cyentia Biosource is a leading biotechnology partner specializing in biospecimen procurement, sourcing, and biobanking solutions for global drug discovery and diagnostic development. We connect researchers with ethically sourced, high-quality human biological samples while ensuring full international regulatory and ethical compliance.
Job Summary / Purpose
The Regulatory Compliance Specialist plays a critical role in ensuring that all biospecimen procurement operations at Cyentia Biosource adhere to the highest international ethical, legal, and regulatory standards. In this role, you will safeguard our procurement workflows by maintaining robust regulatory compliance, authoring and enforcing internal SOPs, and performing remote compliance monitoring of our global vendor and partner network. Your expertise will ensure ethical integrity, traceability, and regulatory compliance.
Key Responsibilities
Regulatory Tracking & Oversight:
- Track and interpret international and regional regulations governing biospecimen procurement, biobanking, and cross-border transport of Human Biological Materials (HBM) (e.g., FDA, EMA, GDPR, HIPAA, ISO 20387).
- Evaluate regulatory and ethical risks associated with incoming biospecimen cohorts and prospective sourcing projects.
Vendor Compliance & Remote Monitoring:
- Perform remote regulatory monitoring, desk audits, and compliance evaluations of external vendors, biobanks, and partner clinics.
- Review and verify vendor accreditations, licenses, collection protocols, Informed Consent Forms (ICFs), and IRB/IEC approvals to ensure full ethical and legal compliance.
- Establish and maintain vendor compliance checklists and tracking tools for onboarding and routine re-evaluations.
SOP & Quality Documentation:
- Author, review, and continuously update Standard Operating Procedures (SOPs) governing regulatory processes, vendor oversight, and biospecimen traceability.
- Coordinate the electronic Quality Management System (eQMS / Cognidox) to ensure proper document control, review cycles, and regulatory compliance.
- Ensure operational workflows strictly align with internal quality standards, customer requirements, and international regulations.
- Support CAPA (Corrective and Preventive Action) tracking and resolution in cases of vendor compliance deviations.
Qualifications & Requirements
Education & Experience:
- Bachelor’s or Master’s degree in Life Sciences, Biotechnology, or a related field.
- 5+ years of experience in Regulatory Affairs, Quality Assurance (QA), or Compliance within Biotech, Pharma, CRO, or Biobanking sectors.
Core Competencies & Knowledge:
- Strong understanding of international biospecimen regulations, ethical standards, GCP/GCLP, ISO 20387 (Biobanking), data privacy (GDPR/HIPAA), and IRB/IEC approval processes.
- Practical experience in performing remote vendor compliance monitoring, desk audits, and reviewing ICFs/protocols (preferably).
- Proven track record in drafting, reviewing, and implementing Standard Operating Procedures (SOPs) from scratch.
Systems & Soft Skills:
- Experience with electronic Quality Management Systems (eQMS). Hands-on experience with Cognidox is a strong plus (experience with similar systems is also acceptable).
- High attention to detail, strong analytical skills, and ability to manage documentation workflows independently.
- Languages: Fluent in English (written and spoken) with proficiency in medical, scientific, and regulatory terminology.
What We Offer
- 100% Remote Work: Fully remote working position, allowing you to work effectively from the comfort of your home office.
- Competitive Compensation: Attractive salary package corresponding to your experience, skills, and qualifications.
- Impactful Mission: Be a key contributor to global biotech, diagnostic, and drug discovery research by ensuring ethical and compliant sourcing of critical biospecimens.
- Professional Growth: Opportunities for professional development, training, and support in obtaining relevant industry certifications.
- Collaborative Environment: A dynamic, supportive, and international cross-functional team with open communication and direct workflows.
For any enquiries regarding this role, please contact us via the form below.
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