Regulatory Affairs Consultant
About The Position
Edison Scientific is seeking an experienced CMC Regulatory Affairs Consultant / Regulatory Affairs Strategy Consultant for a flexible, part-time engagement. The role involves serving as a subject matter expert to define the gold standard for regulatory content, ensuring the platform produces outputs that meet current agency expectations, withstand regulatory scrutiny, and are ready for global submission. This engagement is designed to fit around existing commitments, requiring approximately 5–20 hours per week. The consultant will share knowledge about regulatory submission workflows, identify areas where AI can add value, describe common internal pharma systems, generate or review reference artifacts, and identify sources of variance or data corruption in study data.
Requirements
- 10+ years of experience in Regulatory Affairs within the pharmaceutical/biotechnology industry, ideally with a sponsor.
- Bachelor's Degree required.
- Strong understanding of regulatory requirements and familiarity with ICH guidelines and FDA/EMA expectations.
- Experience supporting regulatory submissions for IND filings.
Nice To Haves
- Advanced degree preferred.
- Familiarity with later-phase and commercial submissions (NDA/BLA, MAA) a plus.
Responsibilities
- Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions.
- Describing common tasks or problems where AI could be of value in your workflows.
- Identify + describe internal pharma systems that are commonly used for standard workflows.
- Generate or review reference ground-truth artifacts to evaluate against - reports, data files, modules, etc.
- Identify + add realistic sources of variance or data corruption in study data.
- Identify and correct discrepancies in data quality.
Benefits
- Competitive salary and equity
- Full healthcare coverage — we pay 100% of premiums for you and your dependents
- Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot
- 401(k) company matching
- $300 health and wellness benefit
- Lunch is on us every day you're in the office, and dinner is on us when you're working late
- Regular team offsites and company events
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What This Job Offers
Job Type
Part-time
Career Level
Senior
