Associate Director, Regulatory Affairs (Remote with Travel)

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:
We are seeking an experienced Associate Director / Director, Regulatory Affairs focusing on the management of clinical regulatory applications (domestic and international) in support of 4DMT’s multiple therapeutics in development. The role requires working closely with 4DMT’s clinical teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of INDs, clinical trial applications, amendments, Agency meeting requests and other regulatory filings. Experience in gene therapy and/or biologics is highly desirable. This position is also responsible for obtaining and interpreting regulations and guidance and providing regulatory advice to clinical departments. Strong communication and management skills are required.
Responsibilities:

• Oversee planning, preparation, and submission of regulatory documents (e.g., protocols, investigator brochures, etc.) and clinical trial applications globally. Ensure that the sections are complete, well-written, and meet all relevant regulatory requirements.
• Oversee planning and preparation for Agency interactions globally, including meeting requests, briefing packages, participating in meetings.
• Develop excellent relationships with internal functional groups, contract research organizations, and 4DMT partners.
• Provide regulatory advice to clinical operations/sciences departments based on knowledge of current regulatory requirements.
• Manage interactions with FDA and other regulatory authorities for assigned projects.
• Respond to agency questions and requests for information.

QUALIFICATIONS:

• BS/MS degree in related discipline required
Experience:

• At least 7 years of experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to the development phase of the product lifecycle)
• Experience in filing INDs and CTAs for pharmaceutical, gene therapy or biologic products in the US and/or Europe is required.
• Experience with Agency interactions is preferred (e.g. Type B/C Meetings with FDA, Scientific Advice interactions with EMA, PIP interactions with PDCO).
Skills:

• Thorough understanding of relevant drug development regulations and guidelines
• Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs.
• Knowledge of the drug development process and global regulations and requirements required.
• Strong analytical skills, problem-solving ability, and presentation skills are required.
• Flexibility and ability to prioritize and manage multiple tasks simultaneously.
• Effective oral and written communication skills.
• Aid in the development of departmental policies and oversee their implementation.   
• Applies strong analytical and business communication skills.
• Knowledge of cGCP (FDA, ICH, and ISO) requirements and FDA regulatory guidelines
• Ability to work independently in a dynamic and changing company environment
• Established track record of clinical Regulatory decision-making 
• Ability to multi-task and support more than one project simultaneously. Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches.
• Strong organizational skills.
• Outstanding interpersonal and communication (written and verbal) skills
• Proficiency with Microsoft Word, Outlook, Sharepoint, and Adobe Acrobat
Physical Requirements of the role:

• Written and verbal communication skills required
• Sitting and computer use for long periods of time
• Adhere to 4DMT Covid protocols and policy including vaccination to work on-site

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

About 4DMT:
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused on three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated, and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity, and, where relevant, having resistance to pre-existing antibodies.

Attention: Search Firms / 3rd Party Recruitment Agencies*
The Talent Acquisition / HR team manages the recruiting for all positions at 4D Molecular Therapeutics. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to 4D Molecular Therapeutics will be considered property of 4D Molecular Therapeutics. 4D Molecular Therapeutics will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions. Recruiters interested in working with 4D Molecular Therapeutics can submit their information to recruiting@4dmt.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.