LifeScience Regulatory Svs Sr Analyst
Core
Assist with data collection and drafting of Chemistry, Manufacturing, and Controls (CMC) documents; perform regulatory operations tasks including bookmarking, hyper linking, and quality control checks for submission components; produce clinical documents throughout the treatment lifecycle.
Role type
Senior Individual Contributor Regulatory Services Analyst
Builds
Regulatory submission documents and clinical reports for potential treatments
Domain
Life Sciences / Regulatory Affairs
Required skills
Clinical & Regulatory Writing, CMC document authoring, ICH guidelines compliance, Source Document transformation, Quality Control (QC) checks, Veeva RIMS/DMS proficiency
Preferred skills
Master of Pharmacy degree, 5-8 years of experience
Technologies
Veeva RIMS, Veeva DMS
Responsibilities
Collect data and draft CMC documents; Collaborate to ensure accuracy of regulatory submissions; Perform bookmarking and hyper linking for granular submission components; Execute QC checks on submission components; Produce clinical documents from trial reporting to post-approval reports.
Seniority
Senior, hands-on IC
