Regulatory Operations Specialist/Assistant
Regulatory Operations Specialist / Assistant Location: United States (Remote) Job Type: Part-Time / Contract Travel: No Travel Required Compensation: USD $50 – $100 per hour (commensurate with experience) 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 experienced Regulatory Operations Specialist to support one of our strategic client partnerships on the East Coast. Position Summary Deep Intelligent Pharma is seeking a detail-oriented Regulatory Operations Specialist to support regulatory submission logistics, document management, and health authority coordination. This role is ideal for someone with strong organizational and execution skills who wants exposure to FDA regulatory processes without requiring a senior-level title.
Key Responsibilities
Regulatory Submission Support
- Coordinate preparation and submission of regulatory packages (INDs, amendments, supplements)
- Organize and manage submission documents across Modules 1–5
- Ensure documents are formatted, version-controlled, and submission-ready
Document & Data Management
- Maintain regulatory document repositories and trackers
- Support document QC (formatting, completeness, consistency)
- Coordinate document flow between internal teams and external partners
FDA Meeting Coordination
- Schedule FDA meetings (Pre-IND, Type B/C, etc.) and manage timelines
- Coordinate meeting logistics, including document submissions and calendars
- Track meeting deliverables, minutes, and follow-up actions
Publishing & Vendor Coordination
- Work with eCTD publishing vendors to support submission timelines
- Track submission status and ensure timely delivery
- Assist in resolving basic technical or document issues
Administrative & Project Support
- Maintain regulatory timelines and milestone trackers
- Support cross-functional coordination (clinical, CMC, regulatory)
- Assist with SOPs, templates, and process documentation
Required Qualifications
- Education:
Bachelor’s degree in life sciences, pharmacy, or related field
- Experience:
1–4 years of experience in regulatory operations, clinical operations, or related role
- Basic understanding of FDA regulatory processes and submission structure
- Strong organizational and documentation skills
Preferred Qualifications
- Experience supporting IND or NDA submissions
- Familiarity with eCTD structure and regulatory document formats
- Experience scheduling or coordinating FDA meetings
- Experience working with CROs, CDMOs, or biotech companies
Skills & Competencies:
- Strong attention to detail and accuracy
- Excellent organizational and time management skills
- Ability to manage multiple tasks and deadlines
- Effective communication and coordination skills
- Proactive and reliable working style
Location & Travel:
- Must be based in United States
- No travel required
What We Offer
- Competitive Hourly rate:
$50–$100 per hour ( commensurate with experience )
- Opportunity to gain hands-on experience in regulatory submissions
- Collaborative, innovative, and supportive company culture
- Remote work environment
- Flexible part-time schedule based on project needs
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