Manager, Regulatory Affairs

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Job description

Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.

Company Differentiators:

• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY

The Manager, Regulatory Affairs at 4D Molecular Therapeutics will be supporting Global Regulatory Lead(s) with regulatory submissions (e.g., IND, CTA, expedited programs, and marketing applications) by leading one or more countries to ensure the successful progress of 4DMT's product pipeline toward regulatory approval and commercialization. The role will work with 4DMT's key stakeholders, cross-functional teams, contract research organizations, and Health Authorities to ensure timely review and approval of various regulatory submissions.

This role can be in-person, remote, or hybrid. Preference is given to SF Bay Area/West Coast candidates or candidates willing to relocate.

RESPONSIBILITIES:

• Supporting Global Regulatory Lead(s) for one or more indications in the strategic planning and execution of US and international Health Authority submissions and approvals.
• Preparing regulatory documents with 4DMT cross-functional team members toward clinical, nonclinical, CMC, and GMO license-related submissions to Health Authorities.
• Coordinating with external vendors and 4DMT teams to provide the necessary documentation to support US and international submissions.
• Supporting the preparation for Health Authority interactions and developing responses to addressing Health Authority queries and information requests.
• Ensuring regulatory submissions' quality, completeness, accuracy, and compliance.
• Tracking, maintaining, and executing submission plans and effectively managing submission deadlines.
• Maintaining regulatory dashboards, plans, timelines, and support tools.
• Providing regulatory guidance to 4DMT team members at a strategic and execution level for the assigned program(s).
• Staying informed about current regulations, guidelines, precedents, industry standards, and competitive landscape to disseminate relevant information to team members to support strategic decision-making.
• Ensuring adherence to all relevant global and local Health Authority regulations, ICH guidelines, industry standards, and 4DMT policies.
• Contributing to Regulatory department initiatives to improve internal policies, standards, and processes.

QUALIFICATIONS:

Education:

• Bachelor of Science

Experience:

• 5+ years of experience in Regulatory Affairs strategy or CMC, preferably in late-stage development.
• Experience filing initial IND/CTA and IND/CTA amendments in more than one region (e.g., US, Europe, Asia-Pacific, and/or Latin America) is required.
• Experience with gene therapy/biologics or ophthalmology therapeutic area desirable.

Knowledge and Skills:

• Knowledge of GCPs, GMPs, GLPs (FDA, ICH, and ISO) requirements and other regulatory guidelines.
• Knowledge of CTD/eCTD structure, format, and submission requirements preferred.
• 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 organizational skills.

Base salary compensation range: $96,000 - $140,000

Please note the base salary compensation range and actual salary offered to the final candidate depends on various factors: the 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

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