Head Regulatory Operations

2 months ago

London, United Kingdom Autolus Ltd Full time

With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Head of Regulatory Affairs Operations & Compliance to join the Autolus team to expand their cell and gene therapy products. Autolus is looking for a Regulatory Operations Leader with proven expertise in eCTD dossier creation and oversight of publishing activities. Experience with implementing regulatory systems and regulatory standards and procedures for dossier management, publishing, archiving and submission processes is preferred.

Key Responsibilities
- Responsible for creating all regulatory submissions in a timely manner together with the regulatory operations team, in collaboration with other regulatory affairs team members, meeting health authority requirements and guidelines from regulatory operation perspective.
- Ensure solid regulatory operations system infrastructure is available to serve global regulatory affairs activities in compliance with global regulatory requirements. Effectively plan eCTD dossier creation, oversight of publishing activities, submission, tracking and archiving to achieve submission excellence and ensure regulatory compliance.
- Proactively lead regulatory operations team in a collaborative and supportive manner. Ensure regulatory operations project assignments enable timely and high quality regulatory submissions. Oversee direct reports in preparation and management of their responsibilities and assist as needed.
- Provide regular performance and activity oversight, develop relevant KPIs to monitor activities ensuring high level quality delivery in a timely manner.
- Serve as regulatory operations contact to regulatory health authorities.
- Manage and implement regulatory systems and processes to ensure achievement of submission excellence and regulatory compliance. Provide input in data migration, update/configuration requirements, integration strategies and change management needs for new and existing systems.
- Develop creative and thorough regulatory operations strategy in collaboration with Global Head Regulatory Affairs based on business needs.
- Assess and develop regulatory compliance architecture further, including required processes and ensure implementation. Contribute to Inspection Readiness and provide support to Audits and Inspection activities.
- Responsible for having awareness of external changes in the global regulatory operations environment, assess the impact, share with relevant stakeholders and implement required changes.
- Ensure training and development for the regulatory operations team.
- Ensure oversight and/or management of contractors & vendors, including responsibility that outsourced activities are delivered on time and on budget, address any risks proactively and transparently.
- Identify potential global regulatory risks to the strategic / operational plans and propose options to mitigate risks.
- Prepare and track regulatory operations budget.
- Leading team initiatives or department initiatives.

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