Job description

Submission Specialist – Regulatory Operations

Conshohocken

Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.

It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.

 

MAIN PURPOSE OF JOB

The Regulatory Operations Submission Specialist will provide support for regulatory submissions and other tasks within the regulatory operations group. The individual will interface primarily with the regulatory affairs team and 3rd party submission vendors and CROs, as well as individuals on the cross-functional program teams from Preclinical, Clinical, Clinical Operations, Safety, Quality, CMC and Commercial.  The position is responsible for managing the logistics, preparation, quality, and delivery of regulatory submissions in accordance with Regulatory Agency requirements, company standards, and timelines. 

The position will also assist in the implementation of an Electronic Document Repository and Regulatory Information Management System and will be responsible for maintaining centralized document management for all projects. The individual will also assist in assessment and implementation of process improvements (e.g., SOP review and creation).

The ideal candidate will have submission experience in the US (INDs, BLA/NDA) and ex-US (CTAs, MAAs). The individual will have a strong regulatory operations skill set for preparing regulatory submissions and managing tasks contracted to external vendors. This role will also require someone who can work within a highly innovative, agile, and entrepreneurial environment and is able to provide regulatory support for the program teams and Regulatory Affairs group.

This is a temporary role, anticipated to be for 12 months.

 

Experience & knowledge

Essential

  • Solid track record in drug development and leadership of submissions that are compliant with health authority requirements for assigned project(s)
  • Excellent knowledge of US regulatory submission requirements. Global experience desirable 
  • Experience representing Regulatory Affairs while working in cross functional teams
  • Experience in supporting global clinical studies
  • Ability to work on multiple projects, while maintaining quality and timelines, and able to prioritize workload with minimal supervision
  • Ability to be agile to accommodate changing priorities
  • Excellent communication and interpersonal skills 
  • Detailed oriented and highly organized 
  • Capable of creating and maintaining logical processes for tracking inventories and filing

Preferred Experience & knowledge

  • Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs. Contribution to part of the submission of at least 1 NME BLA/NDA is highly desirable, but not required.

Education & qualifications

Minimum of 3 to 5 years’ experience in regulatory operations.

 

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position. 

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