CMC Regulatory Professional
4 days ago
Responsibilities:
- Regulatory Documentation and Submissions:
- Prepare 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.
- 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.
- Regulatory Strategy:
- Develop CMC regulatory strategies tailored to cell therapy and ATMP products.
- Monitor and interpret evolving global regulatory guidelines for ATMPs.
- 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.
- Documentation and Systems Management:
- Maintain accurate CMC regulatory documentation and databases.
- Support audits and inspections by regulatory authorities.
Key Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Cell Biology, or related sciences.
- Minimum 3–5 years' experience in a Regulatory CMC role.
- In-depth understanding of regulatory requirements for ATMPs.
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