Hybrid Regulatory Compliance & Permitting Specialist chez Colossal Biosciences

The Regulatory Compliance & Permitting Specialist will lead or support all regulatory and permitting efforts that enable Colossal’s conservation science and synthetic biology programs. You will be responsible for securing and maintaining federal, state, and international permits; managing inventory and documentation for regulated species and biological materials; and ensuring ethical, legal compliance across fieldwork, lab research, and institutional partnerships. This is a highly cross-functional role that collaborates with internal science, legal, and animal operations teams, as well as external regulatory authorities and research partners.

Ideally, this role will be on-site in Dallas, TX. We would be open to a remote arrangement if selected individual could not be in Dallas.

Key Responsibilities

Regulatory Strategy & Permitting

• Lead or assist with obtaining, maintaining, and reporting on regulatory approvals and permits involving:
• Regulated species and conservation fieldwork
• Genetically modified organisms (GMOs)
• Import/export of wildlife specimens and biological materials
• Coordinate with federal and international authorities including USDA/APHIS, USFWS, NOAA, FDA, and frameworks such as CITES, CBD, and the Nagoya Protocol.
• Provide clear, actionable regulatory guidance to research, conservation, and operational teams

Compliance Management

• Develop and implement SOPs and protocols for regulatory compliance
• Conduct internal audits, risk assessments, and gap analyses
• Monitor regulatory and policy developments to ensure ongoing alignment and preparedness

Specimen Inventory & Documentation

• Maintain compliant, detailed inventory records of regulated biological specimens, tracking:
  
  • Species identity and taxonomic classification
  • Provenance and chain of custody
  • Usage, location, and final disposition
• Ensure traceability and documentation from acquisition through transport and storage

Agreements & External Coordination

• Draft and manage loan, donation, and transfer agreements with conservation partners, museums, governments, and academic institutions
• Ensure agreements align with all regulatory, ethical, and data-sharing standards
• Serve as primary regulatory liaison with external partners and collaborators

Cross-Functional Support

• Partner with legal, science, and conservation staff to integrate compliance considerations into all project lifecycles
• Support external policy engagement by translating regulatory frameworks into actionable insights

Required Qualifications

• Bachelor’s degree in Regulatory Affairs, Environmental Policy, Biological Sciences, Law, or a related field
• 10+ years of experience in regulatory compliance, permitting, or legal management in biotech, conservation, government, or research settings
• Demonstrated expertise in U.S. regulatory frameworks (e.g., USFWS, USDA/APHIS, EPA, IACUC) and international treaties (CITES, Nagoya Protocol)
• Proven ability to manage complex regulatory documentation and specimen records
• Excellent attention to detail, organizational skills, and communication abilities

Preferred Qualifications

• Experience with synthetic biology, GMOs, or biospecimen ethics
• Background in managing specimen inventory systems or regulatory asset tracking
• Familiarity with legal agreements involving biological materials (e.g., MTAs, loan agreements)
• Advanced degree (e.g., JD, MS, or PhD) or certification in Regulatory Affairs (RAC)
• Prior work with zoological institutions, academic fieldwork, or government conservation agencies