Arcellx · 10 hours ago
Director, Regulatory Affairs, Ad Promo & Labeling
Redwood City, CA
Full-time
Onsite
Director/Executive
$220K/yr - $255K/yr
10+ years expArcellx is a public, clinical-stage biotechnology company focused on innovative cell therapies for cancer and other diseases. The Director of Regulatory Affairs will lead regulatory compliance efforts, oversee promotional materials, and collaborate with various teams to ensure adherence to FDA regulations and support the company's first product launch.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
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
Qualification
Required
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
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
Relocation assistance
Company
Arcellx
Arcellx is a clinical-stage biotechnology company that provides patients with immune cell therapies.
51-200 employees
H1B Sponsorship
Arcellx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (4)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$622MKey Investors
Kite Pharma
2023-11-15Post Ipo Equity· $200M
2022-12-09Post Ipo Equity· $100M
2022-06-15Post Ipo Equity· $112M
Leadership Team
Michelle Gilson
Chief Financial Officer
Brad Gliner
Vice President, Clinical Research and Regulatory Affairs
Recent News
2025-12-11
2025-12-08
Company data provided by crunchbase