Reporting to the Head of Regulatory, you will provide Regulatory support across all programs.
Ensure Regulatory compliance by managing and maintaining Regulatory submissions across AVROBIO’s portfolios. Interface cross-functionally both within AVROBIO and with external service providers/partners. Pro-actively be aware of evolving regulatory requirements, trends and developments for global studies. Manage and update regulatory archiving databases.
- Coordinate and manage the preparation of regulatory submissions and be responsible for maintenance of IND and CTX related activities.
- Work with and manage CRO Regulatory activities ensuring compliance.
- Provide support in preparation of the response to Health Authority information requests, agency meetings, and serve as a backup liaison between sponsor and the Regulatory
- Manage and maintain regulatory filings and communications archiving databases.
- Contribute to continuous improvement of department processes and SOP creation.
- Implement and assist in the development of regulatory strategies for programs in development.
- Participate in cross-functional program/study team activities to provide regulatory guidance as needed.
- Maintain awareness of evolving regulatory requirements, trends and developments globally.
- Bachelor’s degree required with a minimum of 5+ years pharmaceutical industry experience in Regulatory Affairs.
- Excellent operational skills including planning, organizing and the ability to motivate and gain cooperation from others
- Ability to work independently with minimal direction and to work well within cross-functional teams
- Solid listening, oral and written communication skills.
- Knowledge and experience in interpretation of regulations and guidelines related to drug development
- Experience in multinational global clinical trials
- ECTD publishing experience preferred
- No more than 10%
To apply, email your resume to: email@example.com
AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.