James Harn

Due diligence and new product selection

Head of Regulatory Affairs

Primary/Major Responsibilities: • Participate in project teams, performing scientific and technical oversight and review on development and regulatory documentation. • Ensure adherence to schedule for maintenance of approvals, including supplements to existing approvals. • Keep and maintain USDA permits for importation of raw materials. • Liaise with the Agency, monitor the progress of regulatory submissions, respond to queries and ensure that registration approvals are granted without undue delay. • Serve as the Regulatory Affairs Subject Matter Expert for the US business including evaluation of new and updated FDA policies/guidelines. • In a timely fashion, communicate what impact Agency changes will have on registration strategy. • Provide regulatory support and coordination during customer audits and regulatory inspections of the Hepalink facilities in the US and at Chinese sub- companies, as needed. • Provide training to Regulatory staff in China. • Interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance. • Work collaboratively with the regulatory group in China. • Conduct regulatory due diligence including evaluation and review of documentation for compliance with product licenses. • Provide input into project plans pertinent to regulatory activities. • Work with regulatory contract partners in US.

Lead regulatory activities and serve as regulatory representative on Product Development Teams to provide regulatory support and advice. Facilitate regulatory strategy development and implementation for Product Development Teams and lead regulatory submissions for products. Provide authoring, review, and coordination for quality submissions to regulatory agencies. Prepare for meetings, teleconferences, and other communications (including pre-read packages and/or other necessary documentation) with FDA and other global regulatory agencies. Educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process. • Experience with Orphan Drugs. • Advertising and Promotional Material Review Program Lead • Technical Due Diligence Review member for Mergers and Acquisitions. • Lead development of regulatory strategy for Product Development Teams • Lead preparation of regulatory submissions including pre-IND and formal meetings with FDA, INDs, Annual Reports, and routine correspondence • Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices • Manage and lead a group of regulatory professionals within the Regulatory department • Provide critical review of documentation supporting regulatory applications • Plan, coordinate, prepare and lead meetings and teleconferences with regulatory agencies • Assist in interactions with FDA and other regulatory agencies. • Build professional relationships with FDA project managers and other key personnel, as appropriate. • Communicate with outside regulatory agencies regarding submissions and provide company representation with regulatory agencies to obtain expeditious approval and maintain post-approval compliance • Provide regulatory intelligence for project teams and product development plans.

US Agent representing Xellia to the FDA. Achieved the companies first three ANDA approvals. Conducted Due Diligence reviews for Mergers and Acquisitions. Responsible for filing new ANDA's, 505(b)(2) NDA's and for Portfolio Development Product filing Strategies.

Filed 505(b)(2) NDA's, change control assessments, IND updates for DEA Controlled drugs.

Regional Business Support filing new ANDA and NDA submissions and Life Cycle Maintenance filings of Annual Reports, CBE and PAS supplements. Also managed briefing packages and attended Type B and Type C FDA meetings.

Global Regulatory Affairs Manager supporting the Nutrition business for currently marketed products and development products.

MBA with Certificate in HR