Orchard Therapeutics
Location
Boston, MA | United States
Job description
Location: Boston, US
Reporting to: Executive Director, Regulatory Science, Head of Early-Stage Programs
Job Summary
Early-stage programs encompass all Orchard Therapeutics ex vivo gene therapy assets from preclinical stage up to Phase 3 clinical development. After initiation of the registrational clinical study, programs evolve to the late-stage status.
This role reports to the Head of Regulatory Science for early-stage programs and the successful candidate will be responsible for the successful development and registration of new ex-vivo Gene Therapy Products in the US and globally.
Key Elements and Responsibilities
- Act as US regulatory lead on assigned early-stage program(s)
o Work in close partnership with the Global Regulatory Lead(s) to provide necessary regulatory inputs to the related cross-functional program teams
o Develop the US regulatory strategy, 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)
o Execute the US regulatory strategy:
§ Be the primary liaison with US regulatory authorities for the assigned early-stage programs
§ Plan, prepare, and review submissions to FDA, including Investigational Orphan designation applications (ODD), Investigational New Drug (IND) applications, Fast Track/RMAT designations, 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:
o Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
o Lead the implementation of new US guidance applicable/relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
o Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
o Share expertise and learning experiences - “grow together” approach within the regulatory team
This position offers growth and development opportunities towards a Global Regulatory Lead role for a global development program.
Requirements
Required Experience/Knowledge
- Substantial and hands-on expertise in the development and execution of US regulatory strategies for development programs in industry-related US Regulatory Affairs
- Expert knowledge and understanding of US CFR and FDA guidelines is a must – knowledge and 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 must
- Track record of INDs preparation and management up to FDA clearance
- Track record of management of major health authority interactions (e.g. pre-IND meeting, EOP1, EOP2 meetings etc.), including briefing books preparation, team preparation and meeting leading, is a must
- Experience of regulatory submissions project management
- Knowledge and experience of development of cell or gene-based therapy is a plus
- Previous experience in the preparation and submission of BLA is a plus
- Previous experience with ex-US authorities is a plus
- Regulatory Affairs certification is a plus
Education
- PharmD or PhD in a scientific discipline
Skills and Abilities
- Ability to work in a cross-functional team environment; ability to work with remote teams
- Strong collaboration mindset
- Strong attention to detail
- Excellent organizational skills, ability to handle multiple tasks simultaneously and prioritize effectively
- Proven computer and documentation skills
- Strong interpersonal skills including verbal and written communication (essential in a highly collaborative work environment and to interact efficiently with Authorities)
Job tags
Salary
