Position Description

Regulatory Affairs Manager/Associate Director
Location Lexington, MA
Employment duration Full time
ID 374
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AgenTus Therapeutics is a dynamic new start-up subsidiary developing T cell receptors (TCRs) and chimeric antigen receptors (CARs) designed to supercharge human immune effector cells to seek and destroy cancer. We aim to deliver cures to cancer patients around the world by leveraging our proprietary platforms for TCR discovery, targeting novel phosphopeptide neo-epitopes and developing unique allogeneic cell therapies. Together with our parent company, Agenus, we have a deep and diverse repertoire of immunotherapy treatments that can be used in combinations that will synergize to help the body’s immune system fight cancer.

We are seeking a Regulatory Affairs Manager (RAM) to join AgenTus as part of a cross-disciplinary team to lead the advancement of our iNKT platform to the market. The RAM will have opportunities to grow their career through the acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment and will report to the Chief Operating Officer.

 

The RAM will maximize opportunities for product approval and promote its safe use and further development by:

  • Leading global regulatory strategies that allow drug and CMC development efforts to achieve fast regulatory approval and optimal product label and to support commercial success
  • Delivering regulatory milestones and timely registration throughout the product lifecycle
  • Ensuring patient safety by early identification of safety signals, building robust PhV systems and leading the execution of post-marketing commitments
  • Proactively engaging with and influencing regulatory agencies and healthcare organizations to facilitate product approval and market penetration

 

The RAM will oversee the development and implementation of global regulatory CMC strategies for product development and commercialization, providing regulatory CMC leadership across projects, teams and committees. The RAM will provide strategic and operational leadership for regulatory CMC activities including submission of regulatory applications and interactions with health authorities.

 

Responsibilities: About the Role

 

  • Design, develop, and implement regulatory CMC strategy across projects
  • Deliver regulatory strategy objectives for global regulatory CMC, including operational risk management
  • Lead and manage regulatory CMC cross-functional team members
  • Develop and maintain relationships with regulatory authorities and respond to regulatory agencies, as needed
  • Provide regulatory CMC expertise and serve as an internal consultant on relevant global regulations and guidelines, the current regulatory environment and regulatory precedent
  • Be recognized internally and externally as an expert in global regulations, guidelines and precedents related to pharmaceutical development and CMC lifecycle management

 

Qualifications: About You

  • Advanced degree in a scientific discipline, preferably PhD or PharmD
  • 8+ years of industry experience in the pharmaceutical or biotech industry
  • 4+ years of experience working in regulatory affairs CMC including managing post-approval changes for commercial products
  • Proficiency in regulatory (FDA, EMA, and ICH) guidelines
  • Strong knowledge of current Good Manufacturing Practices (cGMP) and establishment registration requirements
  • Sound understanding of CMC and QA-related issues
  • Experience in leading and writing CMC submissions
  • Experience in cell therapy is preferred
  • Experience with post-approval management of Quality by Design (QbD) filings and experience with global filings is highly desirable

 

Core Competencies

  • Strategic thinking and strong problem-solving skills
  • Strong interpersonal skills and the ability to communicate effectively with cross-functional teams
  • Strong oral and written communication skills
  • Highly effective planning and prioritization, and the ability to work with all levels of management
  • Proven ability to work with interdisciplinary teams 
  • Fluency in English, written and spoken
  • Knowledge of other languages valuable

 

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