Regulatory Affairs Associate (Contract)

The role

The Regulatory Affairs Associate will support the Regulatory Project Team to ensure product pipeline progress toward regulatory approval and commercialization. This person will work with internal and external stakeholders to ensure timely review and approval of regulatory submissions.

What you will do

• Support US and global submission preparation by drafting and formatting documents.
• Coordinate cross-functional deliverables and schedule submissions.
• Ensure regulatory submissions quality, completeness, accuracy, and compliance.
• Support Health Authority interactions by preparing relevant documents and plans.
• Attend cross-functional and departmental meetings.
• Assist in the maintenance of regulatory dashboards, plans, timelines, and support tools.
• Assist with regulatory intelligence and strategic planning.
• Build and maintain knowledge of applicable regulatory requirements.
• Perform activities in accordance with company procedures and applicable regulations.

Required qualifications

• Minimum Bachelors degree in a relevant field.
• 1+ years of drug development experience in regulatory, clinical research/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 in a team-based environment.
• 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.
• Sedentary work involving sitting most of the time.

Nice to have

• Advanced certificate or degree
• Experience with gene therapy/biologics or ophthalmology therapeutic area

About the company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed to provide multi-year sustained delivery of anti-VEGF biologics.