Associate Director, Regulatory Affairs (Contract)

About the Company

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 for blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection. The lead indication for 4D-150 is wet age-related macular degeneration, currently in Phase 3 development, with a second indication for diabetic macular edema. The Company’s second product candidate, 4D-710, 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.

About the Role

We are seeking an experienced Associate Director, Regulatory Affairs (Contract) focusing on the management of CMC and clinical regulatory applications (domestic and international) in support of 4DMT’s multiple therapeutics in development. This role requires working closely with key stakeholders, cross-functional teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of clinical trial applications and other regulatory filings. Expertise in complex biologics and/or gene therapy is highly desirable. Experience with late-stage, Phase 3 development is preferred. Experience with regulatory interactions and/or submissions to PMDA (Japan), CDE (China), or other international regions is preferable. This position is responsible for obtaining and interpreting regulations and guidance and providing regulatory advice to clinical departments. This role can be in-person, remote, or hybrid.

Responsibilities

• Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and responses to agency correspondence.
• Oversee planning, preparation, and submission of regulatory documents (protocols, investigator brochures, CMC, and nonclinical sections of clinical trial applications) for a Phase 3 clinical trial in Japan and China.
• Ensure that the sections are complete, well-written, and meet all relevant requirements.
• Develop excellent relationships with internal functional groups, contract research organizations, and partners.
• Provide regulatory advice to clinical operations, CMC, and pharmacology/toxicology departments based on knowledge of current requirements.
• Manage responses to questions and interactions with regulatory authorities for assigned projects.
• Respond to agency questions and requests for information.
• Aid in the development of departmental policies and oversee their implementation.
• Apply strong analytical and business communication skills.

Requirements

• B.Sc. minimum.
• 5-8 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 clinical trial applications for pharmaceutical, gene therapy, or biologic products in the US, China, or Japan is desired but not required.
• Thorough understanding of relevant drug development regulations and guidelines.
• Outstanding interpersonal and communication (written and verbal) skills; proficiency with computer and standard software programs.
• Knowledge of the drug development process and global regulations and requirements.
• Strong analytical skills, problem-solving ability, and presentation skills.
• Flexibility and ability to prioritize and manage multiple tasks simultaneously.
• Effective oral and written communication.
• Knowledge of GCPs, GMPs, GLPs (FDA, ICH, and ISO) requirements and other 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 supportively of multiple viewpoints and approaches.
• Strong organizational skills.

Skills

• Proficiency with Microsoft Word, Outlook, SharePoint, and Adobe Acrobat.
• Excellent written and verbal communication skills.
• Strong organizational skills.
• Knowledge of GCPs, GLPs, and GMPs.

Pay

Base salary compensation range: $83.00 - $98.00 per hour. The actual salary offered depends on various factors, including the candidate’s geographical location, relevant work experience, skills, and years of experience.