Remote Director of Research and Analysis, New Ventures

Summary

Join our team as Director of Regulatory Affairs, New Ventures to deliver innovative products through comprehensive regulatory strategies and submissions. This role will work with internal and external partners to achieve marketing approvals under New Ventures.

Requirements

• Working knowledge of FDA processes for combination products, drugs, biologics, and medical device marketing approval
• The ability to write clear regulatory strategies and submissions
• Experience in cross-functional collaboration with Quality, Clinical Affairs, Manufacturing, and R&D
• Computer proficiency in MS Office (i.e., Word, Excel, PowerPoint)
• Excellent verbal and technical writing skills
• Ability to work independently

Responsibilities

• Prepare regulatory strategies for New Ventures projects to enable marketing approvals
• Develop and manage content strategy for regulatory submissions, including clinical trial applications (i.e., IDEs, INDs), new marketing applications supplements, and variations
• Build and maintain relationships within the Regulatory Affairs functional areas, Clinical Affairs, Quality, Operations, New Ventures, and Research and Development (R&D) groups
• Manage products and change controls in compliance with regulations and company policies and procedures
• Represent New Ventures Regulatory on teams such as product development, Clinical, Quality, Marketing, and Operations to negotiate, influence, and provide strategic advice
• Serve as liaison and strategic partner with the FDA
• Manage assigned projects within assigned resources. May supervise others
• Seek expert advice and technical support as required for strategies and submissions
• Prepare and manage regulatory applications, including new applications and amendments, renewals annual reports, supplements, and variations
• Review and revise regulatory submissions to effectively present data and strategy to regulatory agencies
• Regularly inform regulatory management of important timely issues
• Train, develop, and mentor individuals; this may include formal supervisory responsibilities
• Develop and implement policies and procedures within the regulatory affairs department
• Analyze legislation, regulation, and guidance, provide analysis to the organization
• Support combination products and medical devices including design control and change management activities
• Provide regulatory guidance and support for risk management and human factors engineering topics for drug, biologics, device, and combination products