Senior Director, Clinical Regulatory Affairs - Remote

Overview

As our Senior Director, Clinical Regulatory Affairs, you’ll lead and drive Arcellx’s clinical regulatory approval strategy and implementation and oversee post-approval regulatory requirements.

In Short

• 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.

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.
• 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.

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.