Director/Head of Regulatory Affairs & Quality Assurance

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. 
 

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

 

Qualifications:

  • 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.

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