Director, Regulatory Affairs, Ad Promo & Labeling at Arcellx

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jan, 26

Salary

255000.0

Posted On

13 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Advertising, Promotion, Labeling, FDA Regulations, Collaboration, Leadership, Communication, Integrity, Compliance, Biopharmaceuticals, Oncology, Strategic Thinking, Problem Solving, Training, Process Improvement

Industry

Biotechnology Research

Description

Who We Are 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. The “Fine Print” – What You’ll Do 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. Skills and Experience We Look For 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. Rewards at Arcellx Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits. The estimated base salary range for this position is $220,000 - $255,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required. 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. Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com. #LI-Onsite

Responsibilities

Serve as the lead Regulatory representative on the Promotional Review and Medical Review Committees, ensuring compliance with regulations and internal policies. Collaborate with various departments to execute key Commercial campaigns and monitor evolving FDA regulations.