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(Senior) Manager, Regulatory Affairs, Advertising, Promotion

1 month ago

US Remote East Coast, UK, United Kingdom myGwork Full time

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Role Summary

With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced RA Manager to work on innovative and pioneering products across the Autolus cell and gene therapy portfolio in the United States and the UK. The Manager, Regulatory Affairs, Advertising, Promotion & Labeling will be part of the broader global regulatory affairs team with responsibilities in building and refining Autolus's global processes and capabilities, and to provide operational support for Autolus products while ensuring optimal alignment of the company position, Health Authority requirements and commercial opportunities in a high quality and compliant manner.

The successful candidate will be involved with working on innovative and pioneering Regenerative Medicine Advanced Therapy (RMAT)/Advanced Therapy Investigational Medicinal Products (ATMP) to treat cancers and benefit from working with cutting edge technologies and be a key player in developing and advancing Autolus’ innovative portfolio of products.

This position is responsible for participating in the review of promotional/non-promotional material as part of the Medical, Legal and Regulatory (MLR) Committee. This includes QC of all promotional material throughout the review/approval process and ensuring that all feedback is incorporated before materials are approved for distribution, as well as the preparation of the submission of advertising and promotional (AdPromo) materials for Autolus products in the United States. This position is also responsible for review of pertinent new labeling, changes to existing labeling and partnering with cross-functional stakeholders to ensure compliant product labeling.

Key Responsibilities

  • Support the development of regional/local labels for assigned products in line with internal standards and in compliance with applicable regulatory requirements.
  • In coordination with Global Labelling Committee Chair, participates in the review and approval of the Company Core Data Sheet (CCDS) and other key global labeling documents including exceptions between CCDS, the US Prescribing Information (USPI) and/or SmPC and resolution of labeling issues.
  • Track data sources supporting labelling claims, history of labelling negotiations and changes including reasons for labeling differences.
  • Prepare and manage the AdPromo submissions of appropriate materials to FDA according to policies and procedures necessary to maintain compliance.
  • Ensure that changes in USPI are reflected in current promotions and advertising.
  • Develop and maintain current knowledge of regulation of labeling and industry standards for labeling and communicate requirements to others as needed.
  • Partner with marketing/sales training team to assist with prioritization (e.g., launch, sales meetings, label updates).
  • Ensure all promotional materials are properly QC’d through the review process utilizing the cloud-based review system (Veeva PromoMats).
  • The post-holder will be responsible for adhering to all health and safety guidance provided by the Company.
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