Regulatory Affairs Associate (Contract)
Core
Supporting the Regulatory Project Team to ensure timely review and approval of regulatory submissions for late-stage biotechnology product candidates (ophthalmology and gene therapy).
Role type
Regulatory Affairs Associate (Contract)
Builds
Regulatory submissions for 4DMT's product pipeline (4D-150, 4D-710)
Domain
Biotechnology / Ophthalmology / Gene Therapy
Required skills
Regulatory submission preparation, cross-functional coordination, Health Authority interaction support, regulatory intelligence, knowledge of 21 CFR/ICH/GCP, CTD structure knowledge, Microsoft Office/SharePoint proficiency
Preferred skills
Gene therapy/biologics experience, ophthalmology therapeutic area experience, advanced certificate or degree
Technologies
Microsoft Word, Outlook, SharePoint, Adobe Acrobat
Responsibilities
Drafting and formatting regulatory documents, coordinating cross-functional deliverables, scheduling submissions, ensuring submission quality and compliance, preparing documents for Health Authority interactions, maintaining regulatory dashboards and timelines
Seniority
Junior, hands-on IC