Health Care

applicant

Pharmaceutical company located in New Jersey is seeking an experienced Regulatory Manager. This individual will be assigned key projects 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. Qualifications include: 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. Salary range is from $90K to $110K depending on experience. Excellent benefits and a congenial work environment. If you are interested in this position, please send resume in Word format as an attachment to Beverly at bslomka@staffpointe.com. Find more opportunities online or register for free at www.staffpointe.com. Only qualified candidates with an MS Word attached resume and recent, relevant experience will have their resumes considered. Please refer to job# BSX1635