Associate RA Specialist Operations and Publishing
Core
Support the preparation, publishing, validation, and submission of regulatory documents to the FDA for Amoxicillin products.
Role type
Associate Regulatory Affairs Specialist (Operations and Publishing)
Builds
FDA submissions (NDA/ANDA, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages, PADERs) and eCTD sequences
Domain
Pharmaceutical manufacturing / Regulatory Affairs
Required skills
Regulatory document compilation and review, eCTD publishing and validation, FDA/ICH guideline compliance, cross-functional team interface, technical writing, project management
Preferred skills
eCTD software experience, FDA ESG/SPL submission experience, SAP experience, post-approval CMC submission knowledge
Technologies
eCTD publishing software, SAP, PC-based word processing, databases, spreadsheets, Adobe Acrobat
Responsibilities
Author, review, and compile FDA submissions; Publish electronic submissions using eCTD software; Assess regulatory impact of proposed changes to manufacturing; Support interactions with FDA and other regulatory agencies
Seniority
Entry-level to Junior, hands-on IC
