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 consultant will serve as a subject matter expert to define the gold standard for regulatory content, ensuring the platform produces outputs that reflect current agency expectations, withstand regulatory scrutiny, and are ready for global submission. This engagement is designed to fit around existing commitments, at approximately 5–20 hours per week, and is ad-hoc in nature. The role involves collaborating with domain experts to design and build tasks, sharing knowledge about the "day-in-the-life" of an expert working with data for regulatory submissions, describing common tasks or problems where AI could be valuable, identifying internal pharma systems used for standard workflows, generating or reviewing reference ground-truth artifacts, identifying realistic sources of variance or data corruption in study data, and identifying and correcting discrepancies in data quality.
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.
- 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
- Define the gold standard for regulatory content.
- Ensure platform outputs reflect current agency expectations.
- Ensure platform outputs withstand regulatory scrutiny.
- Ensure platform outputs are ready for global submission.
- Share knowledge about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions.
- Describe common tasks or problems where AI could be of value in workflows.
- Identify and 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 and add realistic sources of variance or data corruption in study data.
- Identify and correct discrepancies in data quality.
Benefits
- For consulting opportunities, we do not offer benefits.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Part-time
Career Level
Senior
