Advanced Therapies Regulatory Professional
2 days ago
Job Description
We are seeking a highly skilled and detail-oriented Regulatory CMC Specialist with expertise in cell therapy and ATMP to join our dynamic regulatory affairs team. This is an exciting opportunity to contribute to cutting-edge treatments in a fast-evolving field.
- Regulatory Documentation and Submissions:
- Prepare and review high-quality CMC documentation for regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs) specific to cell therapy and ATMP products.
- Ensure compliance with global regulatory requirements for ATMPs, including gene therapies, tissue-engineered products, and somatic-cell therapies.
- Manage submissions for variations, renewals, and responses to regulatory agency queries.
- Cross-Functional Collaboration:
- Collaborate closely with manufacturing, quality assurance, R&D, and clinical teams to compile technical data for regulatory submissions.
- Serve as the regulatory CMC point of contact for ATMP-specific projects, ensuring alignment with manufacturing and clinical development objectives.
- Regulatory Strategy:
- Develop and implement CMC regulatory strategies tailored to cell therapy and ATMP products, considering the unique regulatory landscape for advanced therapies.
- Monitor and interpret evolving global regulatory guidelines for ATMPs, advising stakeholders on implications for product development and lifecycle management.
- Risk Assessment and Compliance:
- Assess and mitigate risks associated with CMC compliance for complex biological systems and advanced therapies.
- Conduct gap analyses of existing ATMP CMC dossiers, ensuring readiness for inspections and compliance with global regulatory expectations.
- Documentation and Systems Management:
- Maintain accurate CMC regulatory documentation and databases specific to ATMPs, ensuring audit readiness.
- Support audits and inspections by regulatory authorities, particularly regarding manufacturing and quality processes for cell therapies.
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