San Diego, CA
The Manager, Regulatory Affairs will oversee the day to day regulatory submissions for projects outside of the US and will aid in US efforts as needed. 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.
- Prepare and oversee submissions and interactions with health authorities outside of the US, including investigational, marketing, and/or post-licensure regulatory submissions (including INDs/CTAs, annual reports, BLA/NDA/MAAs, etc.) in accordance with the regulations and relevant guidelines (domestic and international).
- Participate in study teams to manage Regulatory activities related to global 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.
- Responsible for assigned activities with the project team.
- Perform other duties as required.
- Bachelor's degree Life/Health Sciences.
- Minimum of 5 years of pharmaceutical/biotech Regulatory Affairs experience, with a minimum of 3 years of experience in Regulatory Strategy outside of the US.
- Experience with Asia Pacific (China) regulatory submissions and health authority interactions a plus.
- Oncology drug development experience preferred; gene therapy experience a plus.
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
- Familiarity with electronic filing (eCTD) and electronic documentation systems (eg, Veeva).
- Strong verbal and written communication skills.
- Excellent computer skills.
- Strong knowledge of current US and ex-US regulatory guidelines, including GCP, GLP, and GMP.
- Ability to work well in a deadline-driven environment.
- Capable of supporting multiple projects simultaneously.