Kirk Rosemark

Xencor, Inc. (06/2019 – Current) San Diego, CA 92130 Vice President, Regulatory Affairs and Quality Assurance • Responsible for managing the company’s Regulatory Affairs and Quality Assurance Departments including the development of all processes and procedures • Develop, review and evaluate regulatory approval strategies for development projects and combinations thereof • Responsible for all regulatory health authority interactions/negotiations • Responsible for the review and approval of all abstracts and publications • Responsible for all Quality Assurance compliance activities • Member of executive leadership team reporting to the CEO

Responsible for staffing and managing the company’s US and EU Regulatory Affairs Department. Develop, review and evaluate regulatory submission strategies for four developmental projects and combinations thereof in oncology. Oversee all interactions/negotiations with the FDA and European Health Authorities.

Responsible for creating, staffing and managing the company’s Regulatory Affairs and Quality Assurance Departments, including developing all processes and procedures. Develop, review and evaluate regulatory submission strategies for three development projects; two in phase 2 with both having orphan drug designation, and one is phase 3 ready. Lead all interactions/negotiations with the FDA at both the Division and District levels including two EOP2 meetings and a pre IND meeting. Responsible for drug safety reporting activities. Review and approval of all abstracts and publications Member of executive leadership team reporting to the CEO

Hired to establish a US presence in the Seattle area which was slated to become the company’s headquarters, and to build and manage the company’s Regulatory Affairs and Quality Assurance Departments. Shortly after joining Tekmira they merged with a NJ based company, and the NJ site became the new headquarters for the combined organization. I was offered a position in the new organization, but chose not to relocate and took a severance package.

Responsible for creating, staffing and managing the company’s Regulatory Affairs, Quality Assurance and Medical Writing Departments. As the Vice President, I am accountable for the following operations: Creating regulatory and quality systems that ensure compliance with Title 21 Code of Federal Regulations. Developing, reviewing and evaluating regulatory submission strategies for projects in varying phases of development. Developing and implementing internal work processes to manage projects. Managing upto fifteen active INDs, three orphan drug application and three compounds undergoing IND enabling activities. Taking the lead during all interactions/negotiations with the FDA at both the Division and District levels. Responsible for drug safety reporting activities. Managing staff development and succession planning. Communicating and implementing regulatory strategies that protect the company’s interests in light of evolving regulations. Review and approval of all abstracts and publications. Providing direction and prioritizing the operations of the Regulatory Affairs, Quality Assurance and Medical Writing Departments. Establishing effective lines of communication both internally and with affiliated companies (international) to support development activities.

Responsible for creating and staffing the company’s initial Regulatory Affairs Department. As the Vice President, my responsibilities were commensurate with the regulatory responsibilities noted under Vice President, Regulatory Affairs and Quality Assurance at Exelixis, Inc. In addition, I was responsible for managing the Drug Safety group. I was accountable for managing six INDs (three drug and three biologic), four orphan drug applications (three US and one European) one of which had been designated as a fast track development project.

Designed the organizational structure and staffed the Regulatory Affairs Department post Solvay Pharmaceuticals’ acquisition of Unimed Pharmaceuticals, Inc. in July 1999. The Regulatory Department consisted of a team of eight Regulatory Affairs professionals with a budget of 1.8 million US dollars. My responsibilities were commensurate with those listed under Vice President, Regulatory Affairs and Quality Assurance at Exelixis, Inc. I was also responsible for staffing and managing all drug safety activities. I oversaw the FDA approval process for two NDAs, and managed the review and approval of all promotional materials. I was also responsible for the management of eight approved NDAs, four INDs, and three orphan drug applications. Solvay Pharmaceuticals, Inc., Marietta, Georgia 30062 Associate Director, Regulatory Affairs – New Business Development & CMC Liaison Directed, coordinated and prioritized the operations of the Regulatory New Business Development and CMC group. This team consisted of three Regulatory professionals. Evaluated on a global basis the regulatory status of potential company/product acquisitions and made regulatory recommendations as to whether these opportunities were viable. Developed and evaluated regulatory submission strategies for projects in varying phases of development. Provided guidance and assistance for the growth and development of staff. Managed the approval process for pending applications. Acted as the primary liaison to the FDA. Reviewed and generated investigational new drug applications, new drug applications, abbreviated new drug applications, supplements, amendments and periodic reports. Responsible for providing timely regulatory evaluation of document revision requests ensuring compliance with approved applications, and the Code of Federal Regulations. Responsible for the management of seven INDs, approximately 20 approved A/NDAs and three NDAs in preparation. Manager, Regulatory Affairs – CMC Liaison

Developed regulatory submission strategies and managed the approval process. Acted as the primary liaison to the FDA. Review and generated investigational new drug applications, new drug applications, abbreviated new drug applications, supplements, amendments and periodic reports. Reviewed validation and technical documents for regulatory submission. Ensured compliance of products with “grandfathered” status. Evaluated Regulatory impact of revision requests to ensure compliance with approved applications and the Code of Federal Regulations.