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Regulatory Affairs Manager/Senior Manager

Company: Autolus Ltd
Location: Rockville
Posted on: September 13, 2020

Job Description:

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

Job Summary With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Regulatory Affairs Manager/Sr. Manager to join the Autolus team to work on innovative and pioneering products across Autolus’ cell and gene therapy portfolio. The Regulatory Affairs Manager/Sr. Manager will be part of the broader regulatory affairs team with responsibilities for planning, preparing, reviewing and submitting regulatory applications to the FDA. 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

Provide US strategic regulatory & project management for gene therapy products from early to late stage clinical development;

In collaboration with the Global Regulatory Lead, develop submission plans and HA interaction plans;

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, paediatric study plans (iPSPs) and BLA documents (including labelling);

Liaise with FDA and prepare for FDA meetings as required;

To stay abreast of cell and gene therapy regulatory intelligence;

Keywords: Autolus Ltd, Rockville , Regulatory Affairs Manager/Senior Manager, Other , Rockville, Maryland

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