Arcellx · 4 days ago
Director, Regulatory Affairs Strategy
Redwood City, CA
Full-time
Onsite
Director/Executive
$240K/yr - $275K/yr
10+ years expArcellx is a public, clinical-stage biotechnology company focused on developing innovative immunotherapies for cancer and other incurable diseases. The Director of Regulatory Affairs Strategy will provide strategic guidance on regulatory requirements for clinical trial and marketing applications, lead regulatory interactions, and communicate regulatory strategies to various stakeholders.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
Responsibilities
Independently provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects
Plan, prepare, and manage submissions to HAs
Lead regulatory interactions with HAs
Represent the regulatory function on cross-functional product development teams, providing innovative strategic and tactical advice to achieve timely and efficient development of programs while ensuring compliance
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams, senior management, and external stakeholders (as relevant)
Deliver clear and engaging presentations to internal teams and senior management
Remain current on Regulatory Intelligence, new guidance documents, and competitive information to provide comprehensive information to program teams
Support or lead non-project activities, as needed such as SOP/standards development
Qualification
Required
Bachelor's degree in life sciences or related field required
10+ years of experience in regulatory affairs with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry is a must, including experience in leadership roles
Experience with oncology products
Knowledge of regulatory requirements across development stages and post-approval is essential
Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements
Strong strategic and analytical abilities, diplomacy, and negotiation skills
Ability to collaboratively influence across multiple functions, and motivate others to accomplish company objectives
Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities
Strong verbal, written, and communication skills for effective interaction with internal stakeholders and external regulatory bodies
Strong leadership 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
Preferred
Experience with regulations for biologics and/or small molecules required
Experience with cell/gene therapy desired
Experience with combination products desired
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 for roles if required
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