Director of CMC Regulatory Affairs

Company Background:

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 Century team is seeking an entrepreneurial and strategic Director/Sr. Director, Chemistry, Manufacturing, and Control (CMC) Regulatory Affairs to play a key role on our cross-functional R&D team. In this role, you will partner with Century's VP, Regulatory Affairs to lead and contribute to our regulatory strategies to expedite development, maximize the probability of success, and mitigate risks. The individual in this position will have the unique opportunity to grow and shape the Regulatory function of a biotech start-up.

Responsibilities:

• Ability to provide CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products
• Track record of identifying and communicating CMC regulatory risk areas and developing alternative courses of action
• Maintains relationships with external regulatory professionals including CMC health authorities
• Proven ability to actively collaborate with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Extensive experience planning, preparing, managing, and reviewing regulatory submissions including INDs, CTAs/IMPDs, briefing documents, responses to queries
• Demonstrated leadership ensuring that regulatory submissions meet standards, quality, and guidance:
• Where applicable, recommend staffing and manage team activities
• Define, manage and coordinate CMC regulatory workflow and budget for consultants and vendors
• Track record of leading interactions with FDA [AF1] and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)
• Ability to remain current on CMC regulatory intelligence including guidelines, compendial requirements, and regulatory trends, and to drive and implement strategic policy decisions
• Initiate and contribute to development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership
• Ability to travel 20%

Qualifications:

• B.S. in a biological science, engineering, or a related field. Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry. Advanced degree (Ph.D., Masters/PharmD) preferred
• 10+ years of biopharmaceutical experience, including at least 8 years of direct experience in Regulatory Affairs CMC or cross-functional CMC Leadership experience

Requirements:

Required:

• Robust experience leading CMC strategy and input for cell therapy, gene therapy, or biologics development programs
• Leadership of regional regulatory interactions
• Experience supporting the development of novel therapeutics, with a strong strategic thinking mindset

Preferred:

• Knowledge and experience in immunology and/or immune-oncology
• Direct responsibility for key aspects of cell or gene therapy technical development
• A solid appreciation of Global Regulatory CMC requirements

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