Director/Head of Regulatory Affairs & Quality Assurance
With this goal in mind, Tizona develops next-generation immunotherapies.
Key Accountabilities/Core Job Responsibilities:
Study Planning and Conduct:
- Develops regulatory strategies for all Tizona development programs
- Coordinates, writes, compiles, as appropriate, document packages for regulatory submissions from development, manufacturing, preclinical and clinical areas per regulations/guidelines and company SOPs to support regulatory applications.
- Oversee the establishment, maintenance, and successful implementation of Regulatory & Quality processes and procedures.
- Develop, Lead, and manage a Regulatory function that complies with global health authority regulatory requirements and guidelines (US FDA, EU, ICH and country specific) and current industry standards of practices with a high degree of operational efficiency.
- Reviews and approves investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US FDA requirements and/or country requirements for initiation of clinical sites and drug shipments.
- Ensure all interactions with Agency personnel (US/Ex-US) are conducted to the highest degree of professionalism while fostering a positive working relationship.
- Establish credibility and confidence with key internal and external colleagues through regular communication and the highest degree of professionalism.
- Create and implement effective quality management resource plans, structures and processes and institute appropriate SOPs. Lead Quality Assurance Working group and governance across cross functional teams
- Manage key relationships and strategic discussion with large pharmaceutical partners, ensuring program advancement, quality discussions, and desirable outcomes.
- Establish and maintain the QA programs, policies, and procedures that encompass GCP, GMP, and GLP. Understand and interpret regulatory agency policies and guidance as it pertains to GXP requirements.
- Develop, implement, and oversee audit-ready quality systems, develop schedule and perform audits, lead/support any investigations or inspections of or by Tizona (GCP/GMP/GLP Vendors and Clinical sites).
- Represent RA/QA, both staff and function, at various internal forums
- Ensure that suppliers and external vendors meet all applicable requirements through the development, implementation, and execution of the Supplier Audit program.
- Develop and execute the RA/QA operating budget.
- Manage external Regulatory and QA consultants
- Minimum 5 years of experience in regulatory oncology in a leadership capacity.
- Excellent working knowledge of US, EU and APAC regulations and guidelines.
- Successful regulatory filings associated with full life-cycle development: IND/NDA/MAA CTA, amendments, and experience with companion diagnostics are an absolute must.
- Minimum of a bachelor’s degree in a life science required. MS or PhD degree is preferred.
- Proven ability to find and create solutions for problems in an innovative way.
- Strong influencing skills and the ability to build strong interpersonal relationships.
- Superb oral and written communication skills with the proven ability to shape and frame to diverse audiences.
- Well-developed interpersonal and problem-solving skills with demonstrated leadership and organizational skills.
Education and Experience Requirements:
- Minimum BA/BS or equivalent degree in scientific discipline
- Minimum 2 years of oncology & early phase experience are required
- 10+ years’ work experience in Regulatory Affairs and Quality
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.