Health Care

applicants

We have a challenging new opportunity for an experienced regulatory professional.  The Regulatory Manager will be assigned key project(s) and handle a variety of regulatory activities, including the following:  preparing and submitting IND/CTA and maintenance; functioning as Regulatory lead in NDA preparation; all day-to-day regulatory submissions; providing strategic regulatory support and expertise for the global project team including defining/managing the timeline and monitoring project budgets. Ideal candidates should have a BS in the Life Sciences, complemented by 5+ years regulatory experience, which MUST include experience submitting an NDA for a new chemical entity; in-depth knowledge of US regulations; hands-on experience preparing different types of regulatory submissions, with eCTD NDA experience a plus; advanced MS Office skills and proficiency with Adobe Acrobat are required, along with excellent verbal and written communication skills. You'll be a highly visible contributor.  We offer an excellent compensation and benefits package and a congenial work environment. MUST HAVE: Recent NDA experience with a new chemical entity. SALARY - 90-110K