GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient's immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. GT BioPharma has an exciting and highly impactful opportunity available for a Vice President, Regulatory Affairs to build the oncology portfolio assets at GT BioPharma. This strategic leader will report into the President, Research and Development and Chief Medical Officer.
- Responsible for development, oversight, and communication of global regulatory strategy for assigned projects.
- Serves as a Core member of the cross-functional Project Team representing the global regulatory strategy for assigned global multi-indication projects.
- Leads Regulatory Project Team for assigned projects.
- Leads or manages leads of cross-functional/cross-regional Regulatory Submission Teams and participates on other sub teams. Oversees submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
- Accountable for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation and regulatory guidance is met for assigned product(s) and territories.
- Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidance, comments on draft regulatory guidance, and communicates changes in regulatory information to project teams and senior management.
- Science degree (PhD, PharmD, MD, MSc) with 12+ years; Bachelor’s degree with 15+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry to includeMarket Applications Submission experience (BLA/NDA/MAA) and experience developing and implementing regulatory strategy and managing complex negotiations with Regulatory Authorities.
- Demonstrated effective verbal, written, negotiation and interpersonal communication skills are required.
- Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and understand current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
- Proven track record with taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments.
- Prior experience leading one or more teams in preparation of submissions and maintenance of licenses.
- Recognized as an expert resource for Regulatory issues for other cross functional departments.
To qualify please email your CV to firstname.lastname@example.org.