Associate Director, Regulatory Science

Orchard Therapeutics

Associate Director leading US regulatory strategy and execution for gene therapy assets at Orchard Therapeutics. Collaborating closely with global teams to ensure compliance and approval processes.

Posted 6/26/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $190,000 - $240,000 per yearWebsite

About the role

Key responsibilities & impact

Act as US regulatory lead on assigned program(s)
Work in close partnership with the Global Regulatory Lead(s) and under the oversight of the Executive Director, Regulatory Science to provide necessary regulatory inputs to the related cross-functional program teams
Develop the US regulatory strategy under the oversight of the Executive Director, Regulatory Science, including any innovative procedures to expedite the path to approval, in line with corporate goals, in partnership with the Global Regulatory Lead(s) and the program regulatory team(s)
Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plans.
Support integrated regulatory planning across clinical, nonclinical and chemistry and manufacturing,
Execute the US regulatory strategy:
Be the primary liaison with US regulatory authorities for the assigned program(s)
Plan, prepare, and review submissions to the FDA, including Orphan designation applications (ODD), Investigational New Drug (IND) applications, Fast Track/RMAT designations, and Pediatric study plans
Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for meetings, and interface with US regulatory authorities
Coordinate and prepare responses to questions and requests for information from US regulatory authorities
Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with the defined timelines
Actively participate in regulatory compliance and regulatory team development:
Monitor, analyze, and disseminate intelligence on US regulatory matters that may affect ongoing development programs
Lead the implementation of new US regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
Participate in internal audits and future HA inspections
Share expertise and learning experiences - “grow together” approach within the regulatory team.

Requirements

What you’ll need

Significant experience in the development and execution of US regulatory strategies for development programs in industry‑related US Regulatory Affairs
Knowledge and experience of development/registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus
Very good knowledge and understanding of US CFR and FDA guidelines is a must – understanding of EMA regulations and guidelines is a plus
Previous experience in using US innovative expedited paths to approval in the frame of global development is a plus
Track record of INDs preparation, management up to FDA clearance and maintenance
Previous experience of leading a team to prepare for and attend major health authority interactions (e.g., pre-IND meeting, EOP1, EOP2 meetings, etc.)
Experience in regulatory submission project management
Previous experience in the preparation and submission of a BLA is a plus
PharmD or PhD in a scientific discipline.
Regulatory Affairs certification is a plus
Strong attention to detail, translating into the ability to produce high-quality regulatory documents.
Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholders
Ability to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changes.
Ability to develop partnerships that support a strong cross-functional and inclusive team environment
Ability to work in autonomy on allocated program(s)
Excellent organizational, computer and documentation skills.
Solution-oriented approach to problem-solving including assessing variables, evaluating fundamental issues, anticipating business impact and providing direction.
General interest in a broad range of Regulatory activities.
Strong interpersonal skills including verbal and written communication.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Orchard Therapeutics Website LinkedIn All Job Openings 201 - 500 employees Founded 2016 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance 💰 $150M Post-IPO Equity on 2021-02 Biotechnology
Pharmaceuticals
Healthcare Insurance Orchard Therapeutics is a biopharmaceutical company pioneering in the development and commercialization of transformative therapies for individuals with severe genetic diseases. The company is focusing on Hematopoietic Stem Cell (HSC) gene therapy, aiming to address unmet medical needs by offering potentially curative treatment options. With a commitment to improving lives significantly impacted by genetic conditions like metachromatic leukodystrophy, Orchard Therapeutics strives to change the treatment paradigm through innovative scientific research and dedication to patients' well-being. Associate Director, Regulatory Science Job not on LinkedIn 🔥 30 minutes ago 🏢🏡 Boston – Hybrid 💵 $190k - $240k / year ⏰ Full Time 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Act as US regulatory lead on assigned program(s)
Work in close partnership with the Global Regulatory Lead(s) and under the oversight of the Executive Director, Regulatory Science to provide necessary regulatory inputs to the related cross-functional program teams
Develop the US regulatory strategy under the oversight of the Executive Director, Regulatory Science, including any innovative procedures to expedite the path to approval, in line with corporate goals, in partnership with the Global Regulatory Lead(s) and the program regulatory team(s)
Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plans.
Support integrated regulatory planning across clinical, nonclinical and chemistry and manufacturing,
Execute the US regulatory strategy:
Be the primary liaison with US regulatory authorities for the assigned program(s)
Plan, prepare, and review submissions to the FDA, including Orphan designation applications (ODD), Investigational New Drug (IND) applications, Fast Track/RMAT designations, and Pediatric study plans
Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for meetings, and interface with US regulatory authorities
Coordinate and prepare responses to questions and requests for information from US regulatory authorities
Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with the defined timelines
Actively participate in regulatory compliance and regulatory team development:
Monitor, analyze, and disseminate intelligence on US regulatory matters that may affect ongoing development programs
Lead the implementation of new US regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
Participate in internal audits and future HA inspections
Share expertise and learning experiences - “grow together” approach within the regulatory team. 🎯 Requirements
Significant experience in the development and execution of US regulatory strategies for development programs in industry‑related US Regulatory Affairs
Knowledge and experience of development/registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus
Very good knowledge and understanding of US CFR and FDA guidelines is a must – understanding of EMA regulations and guidelines is a plus
Previous experience in using US innovative expedited paths to approval in the frame of global development is a plus
Track record of INDs preparation, management up to FDA clearance and maintenance
Previous experience of leading a team to prepare for and attend major health authority interactions (e.g., pre-IND meeting, EOP1, EOP2 meetings, etc.)
Experience in regulatory submission project management
Previous experience in the preparation and submission of a BLA is a plus
PharmD or PhD in a scientific discipline.
Regulatory Affairs certification is a plus
Strong attention to detail, translating into the ability to produce high-quality regulatory documents.
Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholders
Ability to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changes.
Ability to develop partnerships that support a strong cross-functional and inclusive team environment
Ability to work in autonomy on allocated program(s)
Excellent organizational, computer and documentation skills.
Solution-oriented approach to problem-solving including assessing variables, evaluating fundamental issues, anticipating business impact and providing direction.
General interest in a broad range of Regulatory activities.
Strong interpersonal skills including verbal and written communication. 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 Supervisor, Credentialing and Regulatory Operations 🕒 3 days ago Guardian Life 5001 - 10000 💸 Finance 🧘 Wellness Website LinkedIn All Job Openings Supervisor role for managing dental provider credentialing and regulatory compliance at Guardian. Overseeing teams to ensure accurate and timely account processes with a focus on customer experience. 🏢🏡 Boston – Hybrid 💵 $82.8k - $136k / year 💰 Non Equity Assistance on 2016-08 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Associate Director, Advertising and Promotional Compliance 🕒 June 5 AstraZeneca 10,000+ employees 🧬 Biotechnology 💊 Pharmaceuticals 🔬 Science Website LinkedIn All Job Openings Associate Director leading US advertising and promotional compliance strategy for AstraZeneca products. Ensuring compliance with FDA regulations and collaborating with cross-functional teams. 🏢🏡 Boston – Hybrid 💵 $150k - $225k / year 💰 Post-IPO Debt on 2023-02 ⏰ Full Time 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Senior Director, Regulatory Affairs 🕒 May 12 Bicara Therapeutics 51 - 200 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Senior Director of Regulatory Affairs leading US strategy for oncology development at Bicara Therapeutics. Responsible for global regulatory submissions and team management in a hybrid work environment. 🏢🏡 Boston – Hybrid 💵 $275k - $315k / year ⏰ Full Time 🟠 Senior 🚔 Compliance GRC Manager 🕒 May 12 CloudZero 11 - 50 ☁️ SaaS 🤖 Artificial Intelligence 💸 Finance Website LinkedIn All Job Openings GRC Manager responsible for governance, risk, and compliance at CloudZero, a cloud cost management platform. Collaborating across teams and ensuring regulatory alignment for business success. 🏢🏡 Boston – Hybrid 💰 Series A on 2021-03 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance Pharmacovigilance Compliance and Oversight Manager 🕒 April 28 Galderma 5001 - 10000 💄 Beauty 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Pharmacovigilance Compliance and Oversight Manager responsible for overseeing PV quality management systems. Ensures compliance with U.S. and global pharmacovigilance regulations, supporting inspection readiness and continuous improvement initiatives. 🏢🏡 Boston – Hybrid 💵 $130k - $180k / year ⏰ Full Time 🟡 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 Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder 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

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Hard Skills & Tools

US regulatory strategyregulatory submission project managementIND preparationBLA preparationFDA guidelinesCFR knowledgeregulatory complianceOrphan designation applicationsInvestigational New Drug applicationsFast Track/RMAT designations

Soft Skills

attention to detailcollaborative working relationshipability to handle multiple tasksplanning and prioritizationautonomyorganizational skillsproblem-solvinginterpersonal skillsverbal communicationwritten communication

Certifications

Regulatory Affairs certificationPharmDPhD