Regulatory Affairs Associate (Contract)

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

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

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.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities