Regulatory Affairs Associate (Contract)

GENERAL SUMMARY

The Regulatory Affairs Associate at 4D Molecular Therapeutics, Inc. (4DMT) will be supporting the Regulatory Project Team (RPT) to ensure the successful progress of 4DMT’s product pipeline toward regulatory approval and commercialization. The role will work within the RPT and with both internal and external stakeholders to ensure timely review and approval of various regulatory submissions.  

This role can be remote or hybrid. Strong preference is given to SF Bay Area/West Coast candidates. 

MAJOR DUTIES & RESPONSIBILITIES:

• Support US and global submission preparation by drafting and formatting relevant documents, coordinating cross-functional (e.g., CMC, nonclinical, and clinical) deliverables, and scheduling 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. 
• Builds and maintains current knowledge of applicable regulatory requirements and performs assigned activities in accordance with company procedures and applicable regulations. 
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. 

QUALIFICATIONS: 

Education:  

• Minimum Bachelors degree in a relevant field. 
• Advanced certificate or degree a plus. 

Experience:  

• 1+ years 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 a plus. 

Other Qualifications/Skills:  

• 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, cooperatively and supportive of 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. 

Travel: <5% 

Physical Requirements and Working Conditions: 

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). 

Base salary compensation range: $36.00-$39.00/hour

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.