Director, Regulatory Affairs Strategy
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. What Matters to Us Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team. Arcellx Core Values Start with authenticity: We foster an inclusive environment where each person can bring their authentic self to work. Think ‘we’ before ‘me’: We prioritize collective success, collaborating and supporting one another to achieve our shared goals. Embrace the challenge: We deliver exceptional results by working with shared determination and a commitment to doing what’s right.
Requirements
- 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.
- Experience with regulations for: Biologics and/or small molecules required
- 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.
Nice To Haves
- Cell/gene therapy desired
- Combination products desired.
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.
Benefits
- Our market-leading benefits package includes: 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 and more.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
