Job Description

We are seeking a highly skilled and proactive Regulatory Affairs Consultant to support our clinical-stage regulatory programs. Preference will be given to candidates based on or comfortable working West Coast U.S. hours . Please note this is initially a 20 hour contract, likely to increase to 40 in the near future

Key Responsibilities

• Provide hands-on regulatory support for IND and CTA-stage clinical programs (non-CMC focus)
• Prepare and manage submissions for INDs, CTAs, and EU CTR filings
• Assist in planning and execution of regulatory interactions , including FDA meeting preparation
• Collaborate across cross-functional project and study teams , ensuring regulatory alignment
• Maintain documentation and version control using Veeva Vault (experience preferred)
• Contribute to regulatory strategy development and execution for clinical programs

Qualifications

• 2–10+ years of relevant Regulatory Affairs experience with clinical-stage (IND/CTA) programs
• Solid experience with U.S. IND submissions. EU CTR/ CTA experienced preferred
• Proven track record supporting FDA submissions
• Experience using Veeva Vault or similar regulatory document management systems is ideal
• Strong cross-functional team collaboration and project coordination experience
• Highly organized, detail-oriented, and able to work independently in a fast-paced environment

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