Director, Regulatory Affairs, Ad Promo & Labeling

Arcellx • Redwood City, CA

88d • $220,000 - $255,000

About The Position

Arcellx is a public, 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 destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.

Requirements

• Bachelor’s degree in life sciences or related field required.
• 10+ years of regulatory affairs experience in the biopharmaceutical industry, with significant expertise in advertising, promotion, and labeling.
• In-depth understanding of FDA regulations and guidelines, and other relevant health authority requirements for pharmaceuticals.
• Ability to apply regulatory knowledge to develop practical solutions and strategies for complex promotional and labeling issues.
• Proven track record of supporting pre-launch through commercial stages, ideally in oncology or specialty pharmaceuticals.
• Ability to operate strategically while managing hands-on responsibilities in a small, fast-paced biotech environment.
• Strong leadership, verbal/written communication, and collaboration skills with the ability to influence internal/external stakeholders.
• High level of integrity and commitment to regulatory compliance in support of patients and healthcare providers.

Responsibilities

• Serve as the lead Regulatory representative on the Promotional Review and Medical Review Committees.
• Independently review and approve promotional/non-promotional materials.
• Ensure regulatory compliance with the current labeling, applicable regulations, guidance documents, and internal policies/best practices.
• Collaborate with Medical, Legal and Commercial to execute and approve key Commercial campaigns.
• Monitor evolving FDA regulations, enforcement actions, and industry best practices; translate insights into internal training and process improvements.
• Develop and implement labeling strategies, including creation, review, and maintenance of prescribing information, patient information, and packaging components.
• Serve as primary liaison with FDA’s Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) on ad promo submissions, inquiries, and regulatory correspondence.
• Contribute to broader regulatory strategy and operations as a key leader within a small, agile team preparing for its first product launch.

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.
• Annual bonus based on company goals.
• Equity (RSU) grant.
• Relocation assistance for roles if required.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees