Key Requirements and Technology Experience:Key skills: Regulatory submission, Technical Writer/Regulatory Writing, AuthoringCMC Regulatory AuthoringRegulatory submissionsBS/BA, MS, or PhD , from an accredited school in a science/health field (e.g., Biology, Analytical Chemistry, Pharmacy, or a related field).Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3).A background in pharmaceutical manufacturing or quality control/quality assurance is a plus. Responsibilities:The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines.