Arcellx, Inc.
Director, Regulatory Affairs, Ad Promo & Labeling New Redwood City, CA
Arcellx, Inc., Redwood City, California, United States, 94061
Director, Regulatory Affairs, Ad Promo & Labeling
Redwood City, CA 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. What Matters to Us
Living our core values is essential to maintaining a high?performing, inclusive, and collaborative work environment. We look for candidates who demonstrate strong values alignment and bring diverse backgrounds, viewpoints, and abilities to the team. 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 whats right.
The Fine Print What Youll 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 FDAs 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
Bachelors 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
The estimated base salary range for this position is $220,000??$255,000 per year. Compensation also includes an annual bonus based on company goals, equity (RSU) grant, and relocation assistance if required. Benefits include 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, 401(k) employer contribution, and more. Join Us
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. #J-18808-Ljbffr
Redwood City, CA 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. What Matters to Us
Living our core values is essential to maintaining a high?performing, inclusive, and collaborative work environment. We look for candidates who demonstrate strong values alignment and bring diverse backgrounds, viewpoints, and abilities to the team. 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 whats right.
The Fine Print What Youll 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 FDAs 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
Bachelors 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
The estimated base salary range for this position is $220,000??$255,000 per year. Compensation also includes an annual bonus based on company goals, equity (RSU) grant, and relocation assistance if required. Benefits include 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, 401(k) employer contribution, and more. Join Us
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. #J-18808-Ljbffr