Lead global clinical regulatory activities including strategy and operations for IND/CTA and BLA submissions, liaison with FDA and other health authorities, and support clinical and marketing objectives to ensure compliance and timely approvals.
The Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for company's clinical asset candidates.
Responsibilities
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of company's quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.
Develop regulatory strategies for assigned programs in collaboration with Company's Regulatory senior management and by analysis of guidance’s and assessment of drug developed for similar indication to obtain approval of activities in support of Company's development.
Also support marketing objectives within specified timelines Liaison responsible for communication with FDA and other health authorities for assigned programs Manage/lead regulatory activities associated with Company assigned drug development programs. Management of the planning, preparation and submission of licensing applications (BLA/MAA).
Requirements
• Minimum of 10 years of pharmaceutical industry
• 5 years of regulatory experience
• MD, Ph.D. or Pharm D. Required
Benefits
• Medical, Dental, Vision all Start Day One
• 401k @.50 on the dollar up to 10%, Vested in 4 Years
• 810 Stock Options
• 135 Restricted Shares of Stock
• Outstanding Relocation Package
• Cost of Living Adjustments
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