Senior Director/ Executive Director Regulatory Affairs Lead

2 weeks ago

United Kingdom Autolus Ltd Full time
Vacancy for Senior Director/ Executive Director Regulatory Affairs Lead - Autoimmune

Location: UK/EU/US

Job Summary

Role Summary

With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Global Regulatory Affairs Lead (Senior Director/Executive Director) for AutoImmune to join the Autolus team to expand their cell and gene therapy products. Autolus is looking for a Global Regulatory Affairs Lead with proven expertise in autoimmune INDs, CTAs, global expedited program applications, biologics license applications (BLAs) as well as marketing authorisation applications (MAA). Experience with autoimmune biologics is preferred, experience in cell and/or gene therapy is desired.

The successful candidate will be involved with working on innovative and pioneering Advanced Therapy Investigational Medicinal Products (ATIMPs) to treat various autoimmune diseases and benefit from working with cutting edge technologies and being a key influencer to shape regulatory requirements for such therapies in the globally.

As a key member of the senior regulatory team the candidate will have responsibility for developing the global regulatory strategy and communicating critical issues to Senior Management. The candidate will ensure that the global development strategy for assigned clinical development projects meets global regulatory requirements for approval and over the lifecycle of the product and is in alignment with the Target Product Profile (TPP), commercial strategy, and Autolus portfolio strategy. The Global Regulatory Affairs Lead will be involved in global regulatory policy for the company and represent the company at external meetings and at Industry Associations, as applicable. 

Key Responsibilities
  • Proactively lead development and execution of creative and thorough global regulatory strategies for assigned development project through collaborative partnership and regulatory leadership within the project team with the ability to guide decisions at program level;
  • Provide strategic input on global regulatory pathways and development plans for complex and/critical topics;
  • Function as strategic regulatory partner within cross-functional project team to execute program strategies and deliverables. Serve as regulatory point of contact to the project team and applicable regulatory authorities for assigned projects.
  • Lead evaluation of regulatory risks and develop strategies for resolving complex issues.
  • Oversee submission processes and lead major applications (Investigational New Drug (IND) applications, IND amendments, Investigational Device Exemption applications, Clinical Trial Applications (CTAs), Biologic License Applications, Marketing Authorisation Application and Pre-Market Approvals) as well as orphan designation applications (ODAs), expedited program applications (e.g. Breakthrough, Regenerative Medicine Advanced Therapy, PRIME, Sakigake) and paediatric study plans as applicable;
  • Lead the development of key regulatory documents and reviews documents.
  • Lead response processes, develops strategies for responding to agencies and ensures compliance with Post Marketing Commitments (PMCs)/Post Marketing Requirements (PMRs)
  • Lead key interactions and negotiations with agencies during all stages of product development and application review.
  • Oversee preparation of high quality, detailed regulatory documents using varied information sources in alignment with regulatory guidance, engage in technical writing as appropriate;
  • Oversee global labelling text development in line with regulatory requirements and emerging data.
  • Ensure compliance with Global Regulations and ensure awareness of cell and gene therapy guidelines across the company;
  • Liaise and collaborate with cross-functional team members in Translational Research, Product Delivery, Clinical Operations, Clinical Development, Project Management and external providers to ensure timely and effective regulatory submissions in support of product progression;
  • Responsible for development and training of staff in regulatory matters and to communicate the impact of new regulatory requirements across the Company.
  • Lead team initiatives or department initiatives.
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