Senior Regulatory Affairs Consultant

Location: United States (Remote)

Job Type: Contract/Hourly (Contingent role)

Travel: Occasional travel as needed

Compensation: USD $250 – $450 per hour (based on experience and engagement).

About Deep Intelligent Pharma (DIP)

Deep Intelligent Pharma is a cutting-edge, AI-enabled Contract Research Organization (CRO) transforming clinical trial execution through innovative technology and scientific excellence. We use a dvanced AI to replace large CRO teams for trial design, analysis, writing, translation, and regulatory documentation —all supervised by expert humans.

In February 2026, DIP raised a $170mm Series D round, led by Sequoia and SIG. Founded in 2017, DIP is pioneering a new, AI-native approach to clinical development. Our multi-agent platform performs scientific writing, data management, statistical reasoning, clinical programming, and regulatory compliance with exceptional speed and precision. Trusted by over 1,000 global pharmaceutical companies and biotechs, DIP is transforming how drugs are developed worldwide.

As we expand our clinical development portfolio, we are seeking a highly experienced Senior Clinical Research Associate to support one of our strategic client partnerships on the East Coast.

Position Summary

Deep Intelligent Pharma is seeking an experienced Senior Regulatory Affairs Consultant to support US FDA regulatory strategy and submission activities across a diverse portfolio of therapeutic modalities.

The ideal candidate will play a high-impact, hands-on consulting role focused on review, strategic guidance, and submission quality oversight rather than full-time operational ownership.

Key Responsibilities

Regulatory Strategy & Advisory

• Provide strategic regulatory guidance across development stages (pre-IND through NDA/BLA)
• Assess regulatory risks, gaps, and submission readiness across clinical, CMC, and nonclinical packages
• Advise on regulatory pathways, expedited programs, and global development strategies
• Review and refine key documents such as Target Product Profiles and regulatory plans

Submission Review & Quality Oversight

• Perform expert review of IND, NDA, and BLA submission components (Modules 1–5)
• Ensure scientific consistency, regulatory compliance, and alignment across functions
• Review Module 2 summaries for clarity, accuracy, and regulatory positioning
• Support submission readiness assessments and QC strategy

FDA Interaction Support

• Review and provide input on FDA meeting materials (Pre-IND, Type B/C, EOP, pre-NDA/BLA)
• Support briefing document refinement and Q&A preparation
• Advise on regulatory communication strategy and agency expectations

Cross-Functional & Global Support

• Collaborate with clinical, CMC, and nonclinical teams to ensure integrated regulatory strategy
• Support programs with cross-border considerations (e.g., US–China regulatory alignment)
• Review translated or bilingual regulatory documents for accuracy and context

Publishing & Submission Readiness Oversight

• Provide guidance on eCTD structure, granularity, and submission strategy
• Review publishing outputs from external vendors for quality and compliance
• Ensure alignment with FDA technical and formatting requirements

Required Qualifications

• Education: Advanced degree in life sciences (PhD, MD, PharmD, MS) or equivalent experience
• Experience: 8–12+ years of experience in US FDA Regulatory Affairs
• Strong knowledge of ICH guidelines, CTD structure, and FDA regulatory processes
• Hands-on experience reviewing Modules 1–5
• Demonstrated experience leading or supporting IND and/or NDA/BLA submissions

Preferred Qualifications

• Experience across multiple modalities (small molecules, biologics, CGT, combination products)
• Prior FDA interaction experience (meeting strategy, briefing documents, IR responses)
• Familiarity with eCTD publishing and submission lifecycle management
• Experience supporting global regulatory strategies (e.g., FDA + NMPA/EMA alignment)
• Bilingual English/Chinese is a plus

Skills & Competencies:

• Strong regulatory judgment and strategic thinking
• High-level regulatory writing and critical review capability
• Ability to work independently in a consulting environment
• Clear and effective communication with senior stakeholders
• Detail-oriented with strong quality mindset

Location & Travel:

• Must be based in United States
• Opportunity to work across multiple innovative programs and sponsors

What We Offer

• Competitive Hourly consulting rate: $250–$450 per hour (based on experience and scope of engagement)
• Exposure to cutting-edge AI technology transforming clinical research
• Flexible, project-based workload with potential for long-term collaboration
• Collaborative, innovative, and supportive company culture
• Remote work flexibility with domestic traveling