Associate Director, Regulatory Affairs – Contract

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $83 - $98 / hour

⏳ Contract/Temporary

🟠 Senior

🚔 Compliance

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and responses to agency correspondence. • Oversee planning, preparation, and submission of the 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.

🎯 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; 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 required. • Flexibility and ability to prioritize and manage multiple tasks simultaneously. • Effective oral and written communication • Aid in development of departmental policies and oversees their implementation. • Applies strong analytical and business communication skills. • 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 supportive of multiple viewpoints and approaches. • Strong organizational skills.