Associate Director Regulatory Affairs CMC

6 days ago

Rockville, Maryland, United States Arcellx, Inc. Full time
About Arcellx, Inc.

Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.

Our Team

Our team members are talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. 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 Role

We are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. The successful candidate will be responsible for preparing, reviewing, and submitting 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.
Requirements
  • Bachelor's degree, or equivalent, (advanced degree preferred Ph.D., MS) in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmaceutical Sciences).
  • 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.
What We Offer

We offer a competitive compensation package, including a base salary range of $165,000 - $180,000 per year, an annual bonus based on company goals, and an equity (RSU) grant. We also 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.

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