Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Primary Objective Arcellx is seeking a Manager/Senior Manager of Regulatory Affairs who will help oversee the company’s regulatory approvals and implementation, as well as post-approval regulatory requirements. This individual will be part of a small team and is expected interface and effectively communicate with cross-functional members of the Arcellx team. Key responsibilities for this position include leading the preparation of eCTD sections of regulatory submissions, support interactions with regulatory authorities, and if necessary, provide relevant guidance to cross-functional teams to ensure that all applicable regulatory requirements are appropriately met. Main Accountabilities
- Participate in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications
- Manage the preparation of responses to regulatory authority queries
- Participate in meetings with regulatory authorities, including end of phase and pre-BLA meetings
- Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine including accelerated review programs.
- Manage critical regulatory projects and work with team members to resolve issues related to CMC, non-clinical studies, and clinical development
- Collaborate with external consultants, clinicians, CROs to provide regulatory guidance
- Contribute to a high performing regulatory team focused on accountability and meeting and exceeding expectations
- Establish procedures or systems for publishing document submissions
- Develop and maintain standard operating procedures or local working practices
- Organize and maintain regulatory documentation, including submissions and correspondence
- Develop and maintain regulatory deliverables schedule
- Support CMC teams and provide direction on the interpretation and application of global CMC regulations and guidance related to Cell Therapy and proteins
- Participate in global CMC regulatory strategy for Cell therapy product(s)
- Provide accurate regulatory assessments of CMC changes to teams/projects and executes regulatory planning and implementation
- Escalate issues to Management that affect registration, regulatory compliance and continued lifecycle management of the product
- Perform other duties as assigned
Preferred Qualifications
- A minimum of a Bachelor's and/or other undergraduate degree in biological, pharmaceutical, chemical, engineering sciences, or similar is required.
- A minimum of 5 years for Manager/10 years for Senior Manager of experience inclusive of postgraduate education and/or pharmaceutical or health care industry experience or equivalent is required
- A minimum of 5 years of experience developing or contributing to global regulatory affairs or related function (i.e., R&D, quality, reg compliance) is required
- Experience in biologics is required
- Knowledge of EU and FDA regulations is required
- Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is highly preferred
- Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. is highly preferred
- Good understanding of regulatory precedent in the area and requirements for early/late development is preferred
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required
- An understanding of health authority laws, regulations, guidance and regulation submission routes available for assigned products is preferred
- Strong knowledge of electronic document and submissions standards. Experience in eCTD publishing.
- Prior experience in a product development role
- Strong organizational skills
Competencies
- Commitment to ethical scientific investigations and rigorous experimental methods
- Ability and desire to multitask and function in a fast-paced entrepreneurial environment
- Sense of urgency in performance of duties
- Interpersonal skills that promote a collaborative and productive lab environment
- Effective and efficient written and oral communication skills
Submit cover letter and resume Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.