Position Summary:

The position of Director of Regulatory Affairs, New Ventures will work with internal and external partners to deliver innovative products to customers through the preparation of comprehensive regulatory strategies and submissions to achieve marketing approvals under New Ventures.  This role will report directly to the VP of Global Regulatory Affairs.

Major Responsibilities:

Under direction from the VP of Global Regulatory Affairs, the Director of Regulatory Affairs, New Ventures will:

• 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

Skills and Experience:

• 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

Qualifications:

The Director of Regulatory Affairs, New Ventures will have:

• A BS degree in pharmacy, Chemistry, Biology or Pharmacology, Engineering, or a related subject
• At least 10 years’ experience in regulatory affairs. 5 years of pharmaceutical experience (with medical device/combination product developing and implementing successful global regulatory strategies is preferred
• Experience with communication with health authorities (e.g., FDA, Health Canada)
• The ability to operate in a fast developing and changing environment, able to differentiate and prioritize between multiple competing options, without losing sight of the long-term strategic objectives of the company
• Experience with regulatory submissions for novel devices
• Experience with regulatory submissions for Class II and III medical devices