Regulatory Affairs Specialist at Alcon - A Novartis Division

Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD). Submissions are produced with electronic publishing tools in compliance with document management standards. Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs. Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors. May prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.