
Regulatory Compliance Specialist
2 days ago
The Qualified Person serves as the primary point of contact for regulatory matters, ensuring adherence to EU directives. This involves certification and batch release of clinical trial supplies, as well as acting as Responsible Person on the Wholesale Distribution Authorisation (WDA) for Pre-Approval Access activities.
Key Responsibilities:
- Support regulatory authority inspections and audits (GMP/GDP) across the global clinical and commercial supply chain.
- Advise cross-functional teams on quality issue management, regulatory compliance, and continuous process improvement.
- Monitor and integrate global regulatory trends to ensure quality systems and operations remain compliant and efficient.
Required Skills and Qualifications:
- Bachelor's degree in a scientific, engineering, or related discipline.
- Minimum 10 years' experience in the pharmaceutical or biopharmaceutical industry.
- Eligibility to act as a Qualified Person under EU directives.
- Previous experience as a Responsible Person (RP) under a WDA is strongly preferred.
Benefits:
- Opportunity to work with a global organization.
- Potential for career growth and development.
- Competitive salary and benefits package.
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