Senior Manager, Regulatory Science

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. The Regulatory Science Team defines and executes regulatory strategies related to the development, registration and maintenance on the market of gene therapies.

Requirements

• Minimum of 5 years of regulatory experience, focused on the development and registration of biologics and/or ATMPs in ROW countries.
• Experience in Gene Therapy or Cell Gene Therapy products development and registration is a plus.
• Strong knowledge and understanding of targeted ROW regulations for innovative drug development and regulatory requirements.
• Experience in regulatory submission project management in ROW.
• Successful experience in writing and reviewing marketing applications and post-approval submissions for biotech/ATMP products.
• Experience with life cycle management activities in Europe and/or ROW.
• Previous experience in the preparation of major health authority interactions or major filing.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement
• Relocation Assistance