Regulatory Affairs Associate
Associate/Senior Associate, Regulatory Affairs
Location: San Carlos, CA (Hybrid options available)
Industry: Clinical-stage Biopharmaceuticals
A leading clinical-stage biopharmaceutical company is seeking a talented Associate or Senior Associate in Regulatory Affairs to join their growing team. This organization is focused on developing innovative therapeutic antibodies for cancer, autoimmune, and other serious diseases, and offers an exciting opportunity to contribute to impactful drug development programs.
About the Opportunity
You will play a key role in supporting global regulatory submissions and communications with health authorities, managing regulatory archives, coordinating with external eCTD publishing teams, and ensuring the smooth operation of day-to-day regulatory activities.
Key Responsibilities
- Collaborate with cross-functional teams to finalize high-quality, compliant regulatory submissions (eCTD format)
- Prepare and support routine submissions to health authorities under supervision
- Serve as regulatory document and submission support for assigned projects
- Coordinate with the Regulatory eCTD publishing team for document publishing and archival
- Manage regulatory submission trackers, archives, and commitment trackers
- Work with Quality and other departments to ensure data accuracy and integrity for submissions
Qualifications
- Bachelor's degree in a scientific field (advanced degree a plus)
- Minimum 2 years' experience in Regulatory Affairs within biotechnology/biopharmaceuticals
- Experience supporting regulatory submissions (INDs in the US, CTAs in Europe, Australia, Asia)
- Familiarity with ICH, CFR, and global health authority requirements
- Strong organizational and submission management skills
- Proficiency with Microsoft Office, Adobe, and eCTD software
- Excellent interpersonal skills and ability to work collaboratively