Manager, Regulatory Operations

Location
Philadelphia, PA, United States
Posted
Sep 24, 2021
Ref
2727042581
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically-engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role:

The Regulatory Operations Manager will have an extensive background in managing regulatory projects and supporting the compilation of eCTD dossiers. They will have expertise in document management and will be expected to provide support across the regulatory team as well as work with cross-functional teams to meet critical submission deadlines.

Responsibilities:

Internal (within Century)
  • Responsible for formatting regulatory documents in CTD and eCTD format and managing life-cycle submissions, such as INDs, MFs, and BLAs in the US and MAAs and CTAs in Europe - including organizing the submission security, review process, submission content planning, and reviewing submissions for completeness and appropriateness
  • Evaluate and implement Regulatory review, submission and operations tools, processes and strategies, including the use of electronic regulatory documentation review and control systems.
  • Coordinate workload and timing for various programs including interfacing with internal teams and stakeholders to build IND & CTA dossier content plans and routine regulatory submissions
  • Provide intra- or inter-departmental training on preparing submission-ready documents, electronic publishing and submission
  • Develop and maintain a reference library for published literature, study reports and regulatory agency guidelines to support all projects
  • Assist in preparing regulatory support materials for team for regulatory agency interactions, including PowerPoint presentations, speaker notes and other documents, as required
  • Prepare templates for and QC documents for INDs, CTAs, NDAs, CRAs, MAAs, annual reports, amendments and correspondence in collaboration with regulatory affairs project leads
  • Provide document formatting, preparation and quality assessment for regulatory submissions
  • Support the regulatory team on managing and tracking health authority feedbacks and submission deliverables throughout product development cycles

External
  • Primary contact with selected external vendor who will be responsible for publishing and submission


Qualifications:
  • Bachelor's degree (BS or BA)
  • 10 years in regulatory operations with a minimum of 5 years managing regulatory submissions and/or projects including management of complex, multi-stakeholder projects


Requirements:
  • Ability, reliability and willingness to work with all Regulatory Affairs personnel, consultants and vendors
  • Excellent communication, verbal and written skills and familiarity with the requirements and etiquette of telephone and video conferences
  • Ability to establish and build collaborative relationships with staff and colleagues to support developmental programs
  • Previous experience developing eCTD-compliant submission using validated content management system
  • Robust MS Office skills including Word, Excel, PowerPoint, as well as Adobe Acrobat, software for designs, schematics and flow diagrams, literature reference and study report management tools; document organization and document management skills. Experience in use of PleaseReview and Master Control Regulatory Module preferred.
  • Knowledge of and ability to interpret regulatory requirements and guidelines as well as familiarity with regulatory agency websites
  • Flexible and adaptability in order to take on new, unexpected or urgent activities, as required
  • High level of interest in continued learning in order to develop knowledge and new professional skills
  • Possesses strong critical and logical thinking skills