Job Title: Regulatory Affairs Specialist Small Molecules
Location: California, United States
Duration: 6+ Months Contract
Rate: $50 - $55/hr on W2 (Depending on Experience)
Position Summary:
We are seeking an experienced Regulatory Affairs Specialist to support regulatory strategy and submissions for a small-molecule development program within the pharmaceutical/biotechnology industry. The ideal candidate will have strong regulatory affairs experience, hands-on FDA IND submission experience, and a background supporting programs from the preclinical/IND-enabling stage through the clinical transition.
The Regulatory Affairs Specialist will work cross-functionally with nonclinical, CMC, clinical, and external partners and will support regulatory interactions and submissions across the U.S., EU, and other relevant regions.
Key Responsibilities:
- Develop and document regulatory strategy for a small-molecule lead program at the IND-enabling stage.
- Prepare and compile FDA IND submissions, coordinating nonclinical, CMC, and clinical contributions.
- Prepare, conduct, and follow up on Pre-IND meetings, including briefing packages and regulatory questions.
- Define early-phase clinical pathways in Australia, including CTN, HREC, and TGA considerations.
- Support EU regulatory strategy under the Clinical Trials Regulation, including CTA/CTIS activities and scientific advice where applicable.
- Conduct gap assessments against IND requirements and translate findings into actionable workstreams.
- Coordinate with external CROs, CDMOs, regulatory vendors, and publishing partners.
- Establish lean Regulatory Affairs processes and documentation structures within a developing organization.
- Provide regulatory guidance and serve as a technical partner to senior leadership.
Must-Have Qualifications:
- Several years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Demonstrated experience preparing and filing FDA IND submissions.
- Strong small-molecule regulatory experience.
- Experience supporting the transition from preclinical/IND-enabling activities to clinical development.
- Hands-on experience with Pre-IND regulatory interactions.
- Multi-regional regulatory experience, particularly across the U.S. and EU.
- Experience working in small or newly established organizations with limited existing Regulatory Affairs infrastructure.
- Strong cross-functional communication, project management, and stakeholder coordination skills.