Associate Director, Regulatory Science
$190,000–$240,000 year
HybridBoston, Massachusetts, United States
Job Summary
Associate Director, Regulatory Science at Orchard Therapeutics (Boston, hybrid) leads US regulatory strategy for ex-vivo gene therapy programs, acts as US regulatory lead, coordinates FDA submissions (IND, Orphan designation applications, Fast Track/RMAT designations, Pediatric study plans), plans and reviews regulatory documents, and interfaces with US regulatory authorities. The role collaborates with Global Regulatory Leads and cross-functional teams to identify regulatory risks and implement expedited pathways, supports integrated regulatory planning across clinical, nonclinical, and chemistry/manufacturing, ensures regulatory documents meet timelines and compliance, participates in internal audits and regulatory-team development, and contributes to SOPs and process improvements. Required experience includes strong US CFR/FDA guideline knowledge, prior IND/BLA submission experience, and demonstrated leadership in regulatory affairs within the biotech or ATMP space; a PharmD or PhD is preferred with regulatory credentials and a proactive, collaborative, problem-solving mindset.
Required Qualifications
- 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.
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