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Associate Director/Director Regulatory Affairs

Company: Autolus Ltd
Location: Rockville
Posted on: September 12, 2020

Job Description:

Vacancy for Associate Director/Director Regulatory Affairs Location: US – Rockville, Maryland, Headquarters /Option for Full Remote

Job Summary

Seeking an experienced Associate Director/Director to join the Autolus team to work on innovative and pioneering products across Autolus’ cell and gene therapy portfolio. The Regulatory Affairs Associate Director/Director will be part of the broader regulatory affairs team with responsibilities for developing and executing US regulatory strategies.The successful candidate will be involved with working on innovative and pioneering regenerative advanced therapies to treat cancers and benefit from working with cutting edge technologies and be a key player in developing regulatory submissions and advancing Autolus’ innovative portfolio of products.

Key Responsibilities

To provide US strategic regulatory guidance and plans to project/task force teams for key company cell/gene therapy product(s) progressing toward late stage development and regulatory filings;

A focused strategic partner and team player to help meet objectives, identify issues proactively and provide insights and recommendations to help move assigned program(s) forward;

To author/review regulatory documents in collaboration with cross-functional teams e.g. Research, Pre-Clinical, Manufacturing, Clinical, Clinical Operations and liaise with external providers to complete submissions such as FDA briefing packages, Breakthrough/RMAT designations, IND/orphan drug annual reports, pediatric study plans (iPSPs) and BLA documents (including labelling);

Lead regulatory interactions with the FDA serving as the primary FDA contact for key asset(s);

To stay abreast of cell and gene therapy regulatory intelligence;

To provide back-up support for the Executive Director, US Head of Regulatory Affairs, including during their absence;

Keywords: Autolus Ltd, Rockville , Associate Director/Director Regulatory Affairs, Other , Rockville, Maryland

Click here to apply!

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