Manager/Sr. Manager Regulatory Affairs

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Job Summary

The Manager/Sr. Manager Regulatory Affairs will manage and maintain the regulatory submissions across AVROBIO’s portfolios. The individual will interface cross-functionally both within AVROBIO and external service providers/partners. The role will manage and maintain regulatory archiving databases and provide broader support to the Head of Regulatory Affairs.

Cambridge
Regulatory Affairs
Key Responsibilities
  • Coordinate and manage the preparation of regulatory submissions and be responsible for maintenance of IND and CTX related activities.
  • Work with and manage CRO activities.
  • Manage and maintain regulatory filings and communications archiving databases.
  • Contribute to continuous improvement of department processes and SOP creation.
  • Provide support in preparation of the response to Health Authority information requests, agency meetings and serve as a primary or backup liaison when required between sponsor and the Regulatory Agency.
  • Assist developing and manage the implementation of regulatory strategies for the programs in development.
  • Participate in cross-functional program/study team activities to support clinical trial applications and provide regulatory guidance as needed.
  • Maintain awareness of evolving regulatory requirements, trends and developments.
Minimum Requirements/ Qualifications
  • Excellent operational skills including planning, organizing and the ability to motivate others
  • Ability to work independently with minimal direction and to work well within cross-functional teams
  • Solid listening, oral and written communication skills
  • Ability to represent the department on project teams as well build networks to obtain cooperation without relying on authority.
  • Knowledge and experience in interpretation of regulations and guidelines related to drug development
  • Experience in multinational global clinical trials and in the preparation of global regulatory submissions including maintenance activities
  • Experience working directly with FDA and/or other global health authorities.
  • ECTD publishing experience preferred
  • Minimum of 5+ years pharmaceutical industry experience in regulatory affairs
  • Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related subject required, advanced degree preferred
About AVROBIO

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.

AVROBIO, Inc is an EEO employer