Executive Director, Regulatory Strategy Lead

Location
Philadelphia, PA, United States
Posted
Jan 08, 2022
Ref
2833177759
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 Executive Director, Regulatory Strategy Lead will oversee global regulatory activities for assigned clinical pipeline programs. As the regulatory strategy lead, you will be responsible for driving the regulatory strategy for development, registration and lifecycle management. You will be expected to take calculated risks and leverage innovative regulatory strategies that can accelerate the development of assigned products. Initially, you will be expected to execute regulatory filings. As the pipeline progresses, this role is expected to evolve to line management of more junior regulatory scientists. This role will involve the opportunity to represent Century on external committees who focus on driving regulatory policy. In addition, the Executive Director will be the back-up and successor to the VP of Regulatory Affairs.

Responsibilities:
  • Accountable for the regulatory success of high priority and complex cell and gene therapies in hematology and oncology therapeutic areas
  • Executes high quality communications with regulators and makes proposals and gains agreement with internal stakeholders on regulatory strategy
  • Works independently in a role that demonstrates organizational influence within and across functions
  • Serves as project team member, representing regulatory affairs on cross-functional team; proactively collaborates across Century functions
  • Provides inputs into and reviews submission documents to ensure they accurately answer the questions being posed and are consistent with health authority (HA) commitments
  • Approves submissions before dispatching to regulatory authorities
  • Ensures responses to HA questions are handled in a timely manner and in line with the approved product strategy
  • Leads or participates in meetings and prepared company personnel for interactions with HA
  • Develops and updates contingency plans for regulatory strategies
  • Refines regional strategy as new data becomes available and re-assesses as necessary
  • Engages in, influences, and shapes external environment initiatives related to portfolio assets
  • Develops departmental processes and templates
  • Provides input into departmental budget and staffing, managing the strategy budget, including externalized operations support


Qualifications:

  • Typically, a regulatory professional with an advanced degree and highly regarded scientific reputation and stature with 18+ years of relevant professional experience in several different domains or organizations.
  • 10+ years of Regulatory program strategy and/or leadership
  • 5+ years of cell therapy experience is preferred


Requirements:

  • Direct involvement and leadership in interacting with health authorities and leading meetings
  • Knowledge of regulatory procedures and practices and awareness of evolving regulatory initiatives
  • seeks to deepen regulatory knowledge through constant learning
  • shares information and regulatory knowledge with others
  • Demonstrated deep knowledge of the drug development process
  • Demonstrated ability to assess and manage risk in a highly regulated environment
  • Demonstrated strong written, spoken and presentation communication
  • Demonstrated negotiation and influence skills
  • Demonstrated attention to detail
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles


  • Preferences:**
  • Cell and gene therapy and/or Hematology & Oncology experience or education
  • Line management experience and/or experience managing consultants
  • Recent or relevant early development experience
  • Experience with combination product (drug/biologic) and/or companion diagnostic development