Director/Sr. Dir, Regulatory Affairs
Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies.
The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.
Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting the cell types and biological mechanisms responsible for immune suppression in the tumor microenvironment.
General Position Overview:
This position will be responsible for regulatory strategies and management of global regulatory submissions and responses. In this role, emphasis will be on proper strategic and operational planning, collaboration with the Product Development Team (PDT) members, and execution on all aspects of regulatory affairs.
Essential Duties and Responsibilities:
- Lead Regulatory Affairs activities with an emphasis on global regulatory strategy and lead the preparation, review and submission of documents to the FDA and other regulatory authorities
- Work with multidisciplinary project groups to meet established objectives; prioritize projects to meet internal and external deadlines; and provide regulatory guidance
- Function as primary liaison with health authorities and regulatory consultants including managing regulatory meetings
- Manage the internal review and approval process for submissions and regulatory questions and responses
- Manage internal meetings, regulatory vendors around regulatory submissions and maintain internal trackers and databases, as appropriate
- Provide support for pharmacovigilance-related regulatory interactions
- Provide leadership to resolve critical regulatory issues, bring the appropriate experts together as needed
- Build a Regulatory Affairs department, manage budgets and project timelines, identify and address gaps in planning and resourcing
- Provide overall organizational support as company grows its product development pipeline
Education and Experience Requirements:
- Bachelor’s degree in a life sciences, chemistry, or related discipline, advanced degree preferred
- Regulatory affairs certification (RAC) a plus
- 5+ years of hands-on Regulatory Affairs experience involving successful IND and IMPD submissions; experience in NDA/BLA/MAA submissions highly preferred
- Experience in eCTD format and structure
- Knowledge of both GCP and GMP regulations
- Strong analytical and strategic thinking skills, detail-oriented execution of work, and strong written and verbal presentation skills
- Demonstrated excellence in regulatory liaison/strategy including a broad understanding of international regulations, processes and issues in drug development
- Strong project management abilities
- Able to work and communicate well within a multidisciplinary project team and to manage multiple projects simultaneously
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), MS Project, and Adobe Acrobat
Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.