Orchard Therapeutics

Executive Director, Regulatory Science

Orchard Therapeutics

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Lead

About the role

  • Serve as US Regulatory Science subject matter expert and senior advisor to program regulatory teams; define Orchard’s US regulatory strategies across the pipeline.
  • Collaborate closely with assigned US Regulatory lead, European peers, Regulatory CMC team and VP of Regulatory Science to ensure consistent global regulatory approaches.
  • Lead/oversee preparation and review of meeting requests, briefing documents and strategic regulatory filings; prepare cross-functional teams for meetings and interface with US regulatory authorities (FDA).
  • Ensure coherent communications and strong relationships with FDA; anticipate FDA reactions, interpret and assess impact of Agency requests and prepare actionable response plans.
  • Lead US regulatory intelligence and regulatory policy activities: monitor, identify, assess, analyze impact and disseminate relevant regulatory updates; participate in industry associations to advocate on US regulation affecting Orchard’s portfolio.
  • Hold line management responsibilities; support VP of Regulatory Science in management of Regulatory Science resources and budget across programs and oversight of third-party vendors.
  • Ensure team adherence to GxP and Orchard policies/SOPs; participate in regulatory department AOP and budget adherence.
  • Monitor program progress, develop contingency plans, and ensure effective cross-functional collaboration with Clinical, Non-Clinical and Tech Ops/CMC departments.
  • Participate in business development initiatives when relevant; travel internationally (mostly UK/EU) as required.

Requirements

  • PharmD or PhD in a scientific discipline preferred.
  • At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning US regulatory science activities associated with the different phases of drugs lifecycle (development, registration and post-approval), including meetings with FDA, INDs, regulatory designations and expedited programs (orphan, fast track, RMAT, breakthrough, accelerated approval), pediatric study plans, BLA/NDA, post-approval modifications and supplements.
  • Knowledge and experience of preclinical and clinical development of gene or cell-based therapy highly desired; technical development and CMC experience not required.
  • Recent experience in the preparation and submission of a successful BLA(s) is a plus.
  • In-depth knowledge and understanding of FDA regulations, guidelines and “habits” in rare diseases and paediatrics; understanding of EMA regulations and guidelines highly desired.
  • Demonstrated experience leading teams to prepare and conduct major FDA interactions (pre-IND, EOP2, pre-BLA, advisory committee meetings etc.).
  • Active involvement in and genuine interest for regulatory intelligence and US regulatory policy activities.
  • Some knowledge and experience of the US MLR review of AdPromo materials is a plus.
  • Managerial experience and line management responsibilities.
  • Strong leadership and interpersonal skills, excellent verbal and written communication and presentation skills.
  • Strategic and innovative thinker with forward-looking problem-solving and long-term alignment abilities.
  • Ability to independently lead teams and make recommendations to senior management.
  • Ability to work cross-functionally and across cultures, with remote teams and across geographic boundaries.
  • Flexible, solutions-driven, highly accountable and dependable; willingness to "roll-up sleeves" and work autonomously in a fast-paced environment.
  • Excellent organizational, time-management, problem-prevention and problem-solving skills; excellent computer and documentation skills.
  • Experienced in remote collaboration; patience, sustained motivation, resilience, high integrity and strong work ethics.