Company: Skills Alliance
Location: New York
Closing Date: 28 Feb 17
Salary (£): 100,000+
Regulatory Affairs Director Excellent senior opportunity within a clinical stage biotech based in New York City. Role/Responsibilities The Regulatory Affairs Director will be responsible for...
Regulatory Affairs Director
Excellent senior opportunity within a clinical stage biotech based in New York City.
The Regulatory Affairs Director will be responsible for all activities related to document preparation for registration/submission and Regulatory strategy. Reporting into the Regulatory Affairs VP, he/she will be the Regulatory representative for interacting with all functional experts internal/external including global health authorities.
The major functions to be performed:
Lead regulatory operational activities, coordinating at directing resources in preparation of and timely submission to the FDA and other health authorities in support of development programs
Manage and ensure Regulatory compliance for INDs (CTAs) and NDAs (MAAs)
Main point of contact for FDA and other foreign health authorities interaction (e.g. Canada, EU) on behalf of development programs and products
Develop and implement global Regulatory strategies.
Life Sciences (M.S. or Ph.D. (preferred))
Minimum of 7-10 years of experience in pharmaceutical drug development as a regulatory lead.
Track record of successfully bringing new products through development, approval and commercialization.
Thorough understanding of drug development process and FDA regulations is required.
Strong problem solving, negotiation, and multi-functional team leadership skills.
Ability to build cross-functional relationships across the company including Development and Legal & Compliance.
Excellent oral and written communication skills.
Please contact Jon Montague at (646) 300-8341 or click APPLY to send your CV directly.
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