Associate Director, Regulatory Science

Orchard Therapeutics plc; Massachusetts; Hybrid; USD 190,000 - 240,000; Full time

Job summary

Orchard Therapeutics, a Kyowa Kirin company, is seeking a US regulatory expert to lead regulatory strategy and submissions for ex-vivo gene therapy programs. The role reports to the Executive Director, Regulatory Science and is based in Boston with a hybrid work model.

The successful candidate will oversee US regulatory activities, engage with FDA, and drive lifecycle regulatory planning across clinical and manufacturing teams.

Qualifications

• 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 – EMA knowledge a plus.
• Previous experience in using US innovative expedited paths to approval in global development is a plus.
• Track record of INDs preparation, management up to FDA clearance and maintenance.
• Experience leading a team to prepare for and attend major health authority interactions (e.g., pre-IND meeting, EOP1, EOP2).
• Experience in regulatory submission project management.
• Experience in preparation and submission of a BLA is a plus.

Responsibilities

• Act as US regulatory lead on assigned program(s).
• Develop the US regulatory strategy under oversight, including expedited procedures.
• Identify regulatory risks and mitigation strategies; support agency engagement plans.
• Support integrated regulatory planning across clinical, nonclinical, and CMC.
• Execute the US regulatory strategy and liaise with US authorities; plan and review FDA submissions.

Skills

US regulatory strategy

IND submissions

FDA communications

Team leadership

Regulatory project mgmt

Education

PharmD or PhD in a scientific discipline

Regulatory Affairs certification

Job description

Location: Boston, US (hybrid)

Reporting to : Executive Director, Regulatory Science

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.

Job Summary

This role is a unique opportunity to join the Regulatory Science team, which is responsible for the development of global regulatory strategy and execution of regulatory activities for ex-vivo Gene Therapy assets. This role reports to the Executive Director, Regulatory Science located in the US. This position is unique and ideal for someone with a solid US regulatory background who can develop innovative regulatory strategies and apply strong skills in execution, collaboration, problem-solving, and attention to detail to contribute to groundbreaking science.

Key Responsibilities

• 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

Required Knowledge/Experience

• 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

Education / Key Competencies

• 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.

Salary Range :

The anticipated salary for this position will be $190,000 - $240,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-based knowledge, location, and other business and organizational needs. The company may ultimately pay more or less than the posted range. The listed salary is just one component of the overall compensation package. At Orchard Therapeutics North America we provide a comprehensive range of benefits in addition to incentive programs.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States – and this range is specific to Boston and the North-East region of the United States. Candidates hired outside the United States or in a different region of the United States will be eligible for compensation and benefits in accordance with their local market.

Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.

_ Notice to All Applicants: _ Orchard Therapeutics participates in E-Verify