Executive Director, Regulatory Science

Location:                     Boston, MA

Main responsibilities

The Executive Director (ED) Regulatory Science will actively support, and serve as senior advisor to, the program regulatory teams to define Orchard’s US regulatory strategies across the pipeline. As US Regulatory Science subject matter expert, the ED Regulatory Science will closely collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a consistent global approach is used for the development and execution of regulatory strategies.

The ED Regulatory Science will be responsible for leading/overseeing the preparation and for reviewing meeting requests and briefing documents and other strategic regulatory filings. The ED Regulatory Science will also have a key role in the preparation of Orchard’s x-functional teams for meetings, and interface with US regulatory authorities.

This position will indeed be instrumental in ensuring efficient communication and maintaining strong relationships with the US FDA. The successful candidate will make sure Orchard’s communications with the Agency are coherent across programs. The ED Regulatory Science will be able to predict/anticipate FDA’s reactions, interpret and assess the impacts of the requests from the Agency and prepare actionable plans to address them.

The ED Regulatory Science will also lead the US Regulatory intelligence and Regulatory policy activities. This consists in the monitoring, identification, assessment, impact analysis and dissemination of relevant regulatory updates. This extends to the participation in relevant US/international industry associations to advocate on critical pieces of US regulation for Orchard’s portfolio.

The ED Regulatory Sciences will have line management responsibilities.  The ED Regulatory Science will support the VP of Regulatory Science to ensure the appropriate management of Regulatory Science resources and budget across programs.

Other tasks

·         Cultivate a global, collaborative, high-performing, culture.

·         Accountable for ensuring team’s adherence to GxP, as well as all relevant Orchard policies and SOPs.

·         Participate in the development of the regulatory department annual operating plan (AOP) and ensure adherence to annual budget targets, including effective oversight of relevant third party vendors.

·         Monitor progress on program objectives and develops contingency plans as needed.

·         Ensure effective cross-functional collaboration with the Clinical department (including Clinical Science, Clinical Operations, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance), Non-Clinical department and Tech Ops / CMC department as necessary.

·         Participate in business development initiatives for new programs if relevant.

·         Some international travels (mostly to the UK/EU) will be required.

Requirements

Required knowledge and experience

·         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 (i.e. development, registration and post-approval): all types of meetings with FDA, INDs, regulatory designations and expedited programs (orphan, fast track, RMAT, breakthrough, accelerated approval…), pediatric study plans, BLA/NDA, post-approval modifications, supplements…).

·         Knowledge and experience of preclinical and clinical development of gene or cell-based therapy highly desired; experience in the technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested.

·         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 the fields of rare diseases and paediatrics is a must – understanding of EMA regulations and guidelines highly desired.

·         Demonstrated experience in leading a team to prepare and conduct major FDA  interactions (e.g. pre-IND, EOP2 meeting, pre-BLA meeting, advisory committee meeting etc.) needed.

·         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 would be a plus.

·         Managerial experience.

Skills

·         Strong leadership and interpersonal skills including verbal and written communication are essential in this collaborative work