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Regulatory Compliance Specialist
2 months ago
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at PCI Pharma Services. As a key member of our Quality Assurance department, you will play a critical role in ensuring the introduction and maintenance of third-party/clinical products within our organization.
Main Responsibilities- Commercial Release: Develop and maintain Drug Product Files (DPFs) for commercial supply chains, prepare and review product quality reviews for third-party QP release, and ensure compliance with regulatory requirements.
- Clinical Release: Oversee and approve Product Specification Files (PSFs) for clinical supply chains, develop and manage Quality Systems & Compliance to support the maintenance and release of third-party/clinical supply chains, and maintain Approved CMO lists for clinical and commercial supply chains.
- All: Develop and manage Quality Systems & Compliance to support the maintenance and release of third-party/clinical supply chains, prepare and maintain third-party/clinical approved products and supplier lists, and maintain Supply Chain/CMO Risk Registers.
- Strong knowledge of regulatory requirements and compliance procedures.
- Excellent communication and project management skills.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
- Experience with quality management systems and compliance procedures.
As a Regulatory Compliance Specialist at PCI Pharma Services, you will have the opportunity to work with a global network of biopharma companies and their patients, making a meaningful impact on the lives of others. Our company culture values innovation, collaboration, and continuous learning, and we offer a competitive compensation package and opportunities for professional growth and development.