Associate Director, Regulatory Affairs – Contract

4D Molecular Therapeutics

Associate Director for Regulatory Affairs at biotechnology company 4D Molecular Therapeutics. Focused on clinical regulatory applications and managing stakeholder communications across global teams.

Posted 7/29/2026contractRemote • 🇺🇸 United StatesSenior💰 $83 - $98 per hourWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Regulatory Affairs with a thorough understanding of drug development regulations and guidelines, particularly in the pharmaceutical and biotechnology sectors. Proven ability to manage regulatory submissions and communicate effectively with regulatory agencies and internal teams.

Highest-signal resume keywords

Regulatory Affairs ExperienceClinical Trial ApplicationsKnowledge of GCPs, GMPs, GLPsAnalytical SkillsInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationDrug Development RegulationsClinical Trial Application FilingRegulatory Decision-MakingKnowledge of FDA, ICH, ISO Guidelines

Soft Skills

Outstanding Communication SkillsProblem Solving AbilityOrganizational SkillsFlexibilityTeam Collaboration

Tools & Technologies

Standard Software Programs

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryRegulatory PathwaysPhase 3 Clinical TrialGlobal Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account 4D Molecular Therapeutics Website LinkedIn All 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. Associate Director, Regulatory Affairs – Contract Job not on LinkedIn 🔥 2 minutes ago 🇺🇸 United States – Remote 💵 $83 - $98 / hour ⏳ Contract/Temporary 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs CARF Quality & Compliance Consultant, PRN/Contract 🔥 7 hours ago HCO Behavioral Health Services 51 - 200 🏥 Healthcare 🧘 Wellness Website LinkedIn All Job Openings Consultant providing CARF compliance guidance for behavioral health organizations. Engaging in project-by-project basis to enhance compliance with CARF standards and quality improvement initiatives. 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Compliance Officer 🔥 14 hours ago Daman Markets 51 - 200 💳 Fintech 💸 Finance ₿ Crypto Website LinkedIn All Job Openings Compliance Officer developing and implementing compliance programmes for regulatory adherence. Monitoring effectiveness and ensuring awareness of AML/CFT regulations. 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance CMC Regulatory Consultant – Oligonucleotide Therapeutics 🕒 2 days ago MPF Federal, LLC 201 - 500 🏥 Healthcare 📦 Logistics 🏭 Manufacturing Website LinkedIn All Job Openings CMC Regulatory Consultant providing regulatory leadership for oligonucleotide therapeutics development. Collaborating with teams to ensure successful IND submissions and regulatory compliance. 🇺🇸 United States – Remote 💵 $250 / hour ⏳ Contract/Temporary 🟠 Senior 🔴 Lead 🚔 Compliance Regulatory CMC Manager – Small Molecule 🕒 6 days ago Vertex Pharmaceuticals 1001 - 5000 🏥 Healthcare 💼 Consulting 🏭 Manufacturing Website LinkedIn All Job Openings Regulatory CMC Manager responsible for planning, preparing and executing regulatory submissions in pharmaceuticals. Collaborating with cross-functional teams to ensure compliance with regulatory standards. 🇺🇸 United States – Remote 💵 $70 - $80 / hour ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Risk & Compliance Coach 🕒 July 17 Leland 11 - 50 💼 Consulting 📣 Marketing 📚 Education Website LinkedIn All Job Openings Risk and Compliance Coach helping students build risk assessment and management skills. Supporting career preparation through coaching on interviews, negotiations, and networking strategies. 🇺🇸 United States – Remote 💰 Seed Round on 2022-05 ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs