Manager/Sr. Manager Regulatory Affairs

One Kendall Square, Building 300, Suite 201, Cambridge, United States

AVROBIO

Posted on: October 5, 2020

Closing: November 04, 2020

Salary: 125,000 – 149,999

Position Type: Full Time

Job Description

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. Our vision is to bring personalized gene therapy to the world. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a program in Pompe disease.

AVROBIO is powered by the plato® gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, MA, with an office in Toronto, Ontario. Please visit our website www.avrobio.com for more information on who we are, what we care about and how we are bringing these therapies to our patients.

POSITION DESCRIPTION

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.

POSITION 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 backup liaison 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.

Qualifications 

• Minimum of 5+ years pharmaceutical industry experience in regulatory affairs

• Bachelor’s degree required, advanced degree preferred

• 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

• ECTD publishing experience preferred

AVROBIO

Posted on: October 5, 2020

Closing: November 04, 2020

Salary($): 125,000 – 149,999

Position Type: Full Time

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Career Focus: Regulatory/Compliance

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