Regulatory Affairs Associate - Remote/Hybrid Biotech

Regulatory Jobs; Emeryville (CA); Hybrid; USD 50,000 - 54,000; Full time

Job summary

4D Molecular Therapeutics, Inc. seeks a Regulatory Affairs Associate to support the Regulatory Project Team in moving the pipeline toward regulatory approval and commercialization. The role collaborates with internal and external stakeholders to ensure timely, compliant submissions and maintains regulatory dashboards.

This position can be remote or hybrid with a strong preference for SF Bay Area/West Coast candidates.

Qualifications

• Minimum 1 year of drug development experience in regulatory, clinical research/operations, clinical quality assurance, and/or medical writing.
• Experience with gene therapy/biologics or ophthalmology therapeutic area is a plus.
• Basic to intermediate knowledge of 21 CFR, ICH, and GCP guidelines.

Responsibilities

• Draft and format regulatory documents for US and global submissions.
• Coordinate cross-functional deliverables with CMC, nonclinical, and clinical teams.
• Ensure regulatory submissions' quality, completeness, accuracy, and compliance.
• Attend cross-functional and departmental meetings.
• Assist in maintenance of regulatory dashboards, plans, timelines, and support tools.
• Support regulatory intelligence and strategic planning.

Skills

Regulatory submissions

Cross-functional coordination

Document drafting

Attention to detail

Team collaboration

Education

Bachelor's degree

Advanced certificate/degree

Tools

Microsoft Word

Outlook

SharePoint

Adobe Acrobat

Job description

4D Molecular Therapeutics, Inc. seeks a Regulatory Affairs Associate to support the Regulatory Project Team in moving the pipeline toward regulatory approval and commercialization. The role collaborates with internal and external stakeholders to ensure timely, compliant submissions and maintains regulatory dashboards.

This position can be remote or hybrid with a strong preference for SF Bay Area/West Coast candidates.