Senior Director, Clinical Regulatory Affairs

Summary

Join Arcellx, a clinical-stage biotechnology company, as our Senior Director, Clinical Regulatory Affairs. You will lead and drive the company's clinical regulatory approval strategy and implementation, overseeing post-approval requirements. Cultivate productive relationships with regulatory authorities and cross-functional team members to bring transformative therapies to market. This critical role involves developing and executing global clinical regulatory strategies, leading program teams in preparing regulatory submissions, and overseeing interactions with regulatory authorities. You will maintain detailed knowledge of the global regulatory environment for cell therapies and regenerative medicine, supporting internal teams with guidance on global regulations. Arcellx offers a fun, diverse, and supportive work environment.

Requirements

• BSc in natural or health sciences (biology, pharmaceutical sciences, or equivalent)
• 12-15+ years of clinical regulatory affairs experience, including early and late phase research, with strong knowledge of health authority regulations and guidance. Candidates with less experience may be considered at the director level
• Proficiency directly writing submission documents that support clinical trials, marketing applications, and lifecycle management
• Experience interacting with Health Authorities and reviewing materials to ensure compliance with applicable regulatory laws and guidance
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
• Exceptional project management skills, organizational and problem-solving skills
• Eager to learn with a collaborative, team-oriented mindset
• Excellent written and verbal communication skills

Responsibilities

• Develop and execute global clinical regulatory strategies
• Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications
• Oversee strategy and drafting of documents related to interactions with regulatory authority on clinical matters
• Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine
• Support internal clinical and development teams to provide direction on global regulations and guidance

Preferred Qualifications

Remote candidates (those outside the Bay Area or Rockville, MD area) will be considered for the role

Benefits

• 100% coverage for medical, dental and vision for team members and dependents
• Unlimited vacation
• A 3-day weekend every month
• Fully-paid parental leave for up to 6 months
• Tuition reimbursement
• 401k employer contribution