Director, Clinical Regulatory Affairs

March 29

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Arcellx

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We're a clinical-stage biotech company reimagining cell therapy through the development of innovative immunotherapies.

biotechnology • car-t • cell therapy • multiple myeloma • oncology

51 - 200

Description

• Lead and drive Arcellx’s clinical regulatory approval strategy and implementation • Oversee post-approval regulatory requirements • Develop and execute global clinical regulatory strategies • Lead program teams in preparing regulatory submissions • 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) • 10+ years of clinical regulatory affairs experience, including early and late phase research, with strong knowledge of health authority regulations and guidance • 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 • 3-day weekend every month • Fully-paid parental leave for up to 6 months • Tuition reimbursement • 401k employer contribution