What are the responsibilities and job description for the Associate Director, Regulatory Affairs CMC position at Arcellx?
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
- Character: Committed to always doing what’s right.
- Audacity: Willing to challenge convention and share candid feedback with others.
- Determination: Curious and self-motivated. Always looking to improve and learn.
- Collaboration: "No job is too small" mentality. Humble and willing to help others.
- Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
The “Fine Print” – What You’ll Do
- Prepare, review, and submit high-quality regulatory documents, ensuring accuracy and compliance with global regulatory requirements.
- Manage interactions with regulatory agencies.
- Author Standard Operating Procedures (SOPs) and Workflows for regulatory CMC function ensuring effective practices for internal cross-functional collaboration.
- Ensure cross-functional alignment and effective communication of regulatory CMC requirements and strategies.
- Manage collaboration with vendors including communicating and executing the Company’s strategy and preparation of regulatory documents.
- Provide regulatory guidance and support for CMC activities, including process development, scale-up, technology transfer, and validation.
- Monitor and interpret evolving global regulatory CMC requirements and communicate potential impact to internal stakeholders.
- Ensure compliance with regulatory commitments and maintain up-to-date regulatory documentation and databases.
Skills and Experience We Look For
- Bachelor’s degree, or equivalent, (advanced degree preferred Ph.D., MS) in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmaceutical Sciences). Candidates with less experience will be considered at the Senior Manager level.
- Minimum of 8 years of experience in regulatory affairs, with a focus on CMC, within the biotechnology or pharmaceutical industry.
- Proven track record of successful regulatory submissions and interactions with global regulatory authorities.
- In-depth knowledge of global regulatory requirements and guidelines for cell therapy products.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.
- Strong technical knowledge and understanding of CMC processes for biologics with emphasis on cell and gene therapies.
- Self - motivated and proven ability to drive projects to completion, embrace risk, and thrive in fast paced, demanding environment.
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 base salary range for this position is $165,000 - $180,000 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.
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Salary : $165,000 - $180,000
