We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!
Education, Experience and Qualification Requirements :
- Bachelor's Degree in a scientific or mathematical area
- Atleast 2 years experience in a regulatory setting at a biotech company
- Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory matters.
- Experience in supporting regulatory submissions for pharmaceutical development, with a focus on investigational new drug applications (INDs) in the US, as well as clinical trial applications (CTAs) in regions such as Europe, Australia, and Asia.
- Effective submission management skills, with the ability to collaborate with team members to ensure accurate and timely submissions to regulatory agencies.
- Familiarity with regulatory guidelines and requirements (e.g., ICH, CFR) from health authorities.
- Demonstrated ability to work effectively within a team, contribute meaningful input, and demonstrate a willingness to learn new skills.
- Proficiency with Windows, Adobe, and eCTD software.
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