Regulatory Affairs Associate (Contract)

4D Molecular Therapeutics • Emeryville, CA

6d • $36 - $39

About The Position

The Regulatory Affairs Associate at 4D Molecular Therapeutics, Inc. (4DMT) supports the Regulatory Project Team to help advance the company’s product pipeline toward regulatory approval and commercialization. The role works with internal and external stakeholders to facilitate the timely review and approval of regulatory submissions. The position may be remote or hybrid, with a strong preference for candidates in the San Francisco Bay Area or on the West Coast.

The associate supports US and global regulatory submission preparation, including drafting and formatting documents, coordinating cross-functional deliverables, and scheduling submissions. The role also supports Health Authority interactions, maintains regulatory plans and tracking tools, and contributes to regulatory intelligence and strategic planning. Travel is less than 5%.

Requirements

• Bachelor’s degree in a relevant field.
• At least 1 year of drug development experience in regulatory affairs, clinical research or operations, clinical quality assurance, and/or medical writing.
• Basic to intermediate knowledge of 21 CFR, ICH, and GCP guidelines.
• Basic to intermediate knowledge of CTD structure, format, and submission requirements.
• Ability to work cooperatively in a team-based environment and support multiple viewpoints and approaches.
• Flexibility and ability to prioritize and manage multiple tasks and projects simultaneously.
• Proficiency with Microsoft Word, Outlook, SharePoint, and Adobe Acrobat.
• Excellent oral and written communication skills.
• Strong attention to detail and organizational skills.

Nice To Haves

• Advanced certificate or degree.
• Experience with gene therapy, biologics, or the ophthalmology therapeutic area.

Responsibilities

• Support preparation of US and global submissions by drafting and formatting documents, coordinating cross-functional deliverables, and scheduling submissions.
• Ensure regulatory submissions are high quality, complete, accurate, and compliant.
• Support Health Authority interactions by preparing relevant documents and plans.
• Attend cross-functional and departmental meetings.
• Assist with maintaining regulatory dashboards, plans, timelines, and support tools.
• Assist with regulatory intelligence and strategic planning.
• Maintain current knowledge of applicable regulatory requirements and perform assigned activities in accordance with company procedures and applicable regulations.
• Perform other duties as assigned.

What This Job Offers

• Career Level: Entry Level