Associate, Regulatory Affairs
$97,000–$114,000 year
On-sitePalo Alto, California, United States
Job Summary
Support preparation and compilation of regulatory submissions for clinical studies, including CTA and IND filings, and coordinate workflows for FDA and global health authority reviews. Manage submission timelines, maintain trackers for health-authority requests and due dates, and communicate regulatory status, risks, and action items to the RA Lead and cross-functional teams. Prepare regulatory content for BLA, NDA, and ex-US marketing applications while collaborating on document planning and Health Authority meetings. Maintain accurate regulatory and ethics archives under the direction of the Regulatory Affairs Lead.
Required Qualifications
- BA/BS degree in the biological or health related sciences
- Relevant (bio) pharmaceutical industry experience
- experience in regulatory affairs
- Foundational understanding of the drug-development process
- applicable regulatory concepts
- FDA regulations
- ICH guidelines
- Good Clinical Practice
- willingness to develop knowledge of ex-U.S. requirements
- Proficient in written, oral, and interpersonal communications in English
- Ability to work in close collaboration with cross-functional colleagues
- Strong attention to detail
- ability to organize, prioritize, and complete assigned work within established timelines
- Clear and concise oral and written communication skills
- Excellent organizational skills
- Critical thinking
- problem solving
- ability to complete assigned work with appropriate guidance
- ability to escalate questions or risks promptly
- Ability to work effectively in a dynamic, deadline-driven, and collaborative environment
Desired Qualifications
- Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations
- ex-US Health Authority interactions, meetings etc.
- Proficient user of standard MS Office suite (e.g., Word, Excel)
- experience using electronic document management systems
- document review tools
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