Associate Director, Regulatory Science
New
O
Orchard TherapeuticsGene Therapy
United StatesFull-TimeManager
Salary190,000 - 240,000 USD per year
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Job Details
- Required Skills
- Project Management
Requirements
- PharmD or PhD in a scientific discipline.
- Significant experience in developing and executing US regulatory strategies for industry-related development programs.
- Deep knowledge and understanding of US CFR and FDA guidelines.
- Proven track record in IND preparation, management, and FDA clearance maintenance.
- Experience leading teams in preparing for and attending major FDA interactions (e.g., pre-IND, EOP1, EOP2 meetings).
- Experience in regulatory submission project management.
- Strong attention to detail with ability to produce high-quality regulatory documents.
- Ability to work autonomously on allocated programs in a fast-paced, multi-task environment.
- Strong interpersonal skills for cross-functional collaboration and partnership.
- Regulatory Affairs certification is considered a plus.
- Knowledge of biologics, ATMPs, and EMA regulations is considered a plus.
Responsibilities
- Serve as the US regulatory lead for assigned gene therapy programs.
- Develop and execute US regulatory strategies, including expedited approval pathways.
- Act as the primary point of contact for interactions with US regulatory authorities.
- Plan, prepare, and review regulatory submissions including ODD, IND, and BLA applications.
- Coordinate cross-functional teams for FDA meetings and manage briefing document preparation.
- Monitor US regulatory intelligence and implement updates to internal development programs.
- Contribute to regulatory process improvements, SOP development, and audit preparation.
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