Reports To: Director, Regulatory Affairs
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Manager, Regulatory Affairs will oversee the day to day regulatory submissions for one or more projects. May directly interface with regulatory authorities on specific projects or products to ensure the company is adhering to all applicable government regulations and successfully manage multiple projects simultaneously while adapting to changing project priorities.
Duties and Responsibilities Include But Are Not Limited To:
- Prepare and oversee submissions with an emphasis on, but not limited to, CMC, for investigational, marketing, and/or post-licensure regulatory submissions (including INDs/CTAs, IND amendments, annual reports, BLA/NDA/MAAs, BLA/NDA supplements, etc.) in accordance with the regulations and relevant guidelines (domestic and international).
- Provide CMC regulatory support, guidance, and expertise to QA, QC, and Manufacturing teams; develop CMC regulatory strategies for product development, including technical documentation and change controls.
- Participate in study teams to manage Regulatory activities related to product development.
- Assist other departments and submission authors in writing and editing submissions, in compliance with departmental and regulatory standards.
- Research and provide analysis of current regulations and guidance
- Create and manage departmental SOPs and guidelines.
- Produce high quality regulatory submissions in paper or using electronic publishing systems.
- Responsible for assigned activities with the project team.
- Perform other duties as required.
Desired Knowledge and Abilities:
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
- Experience with electronic filing (eCTD) and database management abilities.
- Experience with documentation systems and with document review and auditing.
- Strong verbal and written communication skills.
- Excellent computer skills.
- Strong knowledge of current US and ex-US regulatory guidelines, including Good Manufacturing Practices.
- Ability to work well in a deadline-driven environment.
- Capable of supporting multiple projects simultaneously.
Education & Experience:
- Bachelor’s degree Life/Health Sciences.
- Minimum of 5 years of experience in pharmaceutical / biotech industry, with a minimum of 3 years of experience in Regulatory.
- CMC Biologics experience within biotherapeutics development/GMP operations.
- Oncology drug development experience preferred; gene therapy experience a plus.