Manager, Regulatory Affairs

Responsibilities Preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs Submitting safety reports, amendments, supplements, and license renewals to clinical trial applications Providing regulatory expertise to labeling changes and to submission teams on specified projects & topics Providing input to senior Regulatory Affairs professionals in the preparation of country‑specific labeling Ensuring product packaging and associated information is updated & maintained per product licenses Participating in group meetings and local/global product submission team meetings and presenting project status updates Requirements BS and 7+ years of experience in Regulatory Affairs or other relevant industry experience OR MS and 5+ years of experience in Regulatory Affairs or other relevant industry experience Degree in a scientific field is preferred Excellent organization skills and ability to work on a number of projects with tight timelines is required Excellent verbal and written communication skills and interpersonal skills are required In‑depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories #J-18808-Ljbffr Jobtailor