Manager, Regulatory AffairsPosted: November 18, 2009
Manager, Regulatory Affairs Location: Suffern, NY Exempt/Non-Exempt: Exempt Benefits: Medical Coverage, Dental Coverage, Prescription Drug Coverage, Fertility Drug Benefit, Life Insurance, Accidental Death & Dismemberment, Insurance, Short Term Disability Insurance, Long-term Disability Insurance, Health Care Flexible Spending, Account, Dependent Care Flexible Spending Account, Employee Assistance Program, 401(K) Program, Vacation Program, Personal Days, Holidays, Employment Type: Full Time Department: Regulatory Affairs Description: Responsible for preparing and submitting regulatory information to FDA. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Requests, reviews, prepares and organizes CMC, preclinical, clinical and other documents used in FDA submissions 2. Manages electronic documents and creates electronic submissions in CTD format 3. Serves as a member of Project Teams, as assigned by the Senior Director, Regulatory Affairs, and provides input on the operational aspects and regulatory requirements for FDA submissions (e.g. IND, NDA submissions) QUALIFICATION REQUIREMENTS: BS, Pharm D or PhD 3+ years of hands-on experience working on IND submissions NDA experience desirable but not required Working knowledge of FDA regulations and guidances required OTHER SKILLS & ABILITIES: Excellent organizational and interpersonal skills; good communication and presentation skills; good computer skills. The above is intended to describe the essential job functions and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
Please refer to job code ferringpharma-35314 when responding to this ad.
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