Full-Time

Associate Director

Regulatory Affairs CMC

Confirmed live in the last 24 hours

Arcellx

Arcellx

51-200 employees

Develops immunotherapies for cell therapy

Biotechnology
Healthcare

Compensation Overview

$165k - $180kAnnually

+ Annual Bonus + Equity Grant

Senior, Expert

North Bethesda, MD, USA

Relocation assistance offered if required.

Category
Legal
Risk & Compliance
Legal & Compliance
Requirements
  • 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.
Responsibilities
  • 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.

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products focus on advanced techniques that enhance the body's immune response to fight illnesses. The company collaborates with healthcare providers and research institutions to bring these therapies to patients. Unlike many competitors, Arcellx emphasizes proprietary products and partnerships to drive their research and development efforts. The main goal is to meet unmet medical needs by providing safe and effective treatment options through their innovative approach to cell therapy.

Company Stage

IPO

Total Funding

$194.5M

Headquarters

Gaithersburg, Maryland

Founded

2014

Growth & Insights
Headcount

6 month growth

16%

1 year growth

25%

2 year growth

66%
Simplify Jobs

Simplify's Take

What believers are saying

  • Growing investment in personalized medicine aligns with Arcellx's tailored immunotherapies.
  • Advancements in gene editing like CRISPR enhance precision in engineered cell therapies.
  • Increasing collaboration with academic institutions drives innovation in cell therapy.

What critics are saying

  • Competition from established CAR-T therapies like Abecma and Carvykti could limit market share.
  • Reliance on partnerships like with Kite poses risks if disruptions occur.
  • Significant financial commitments in partnerships could strain resources if outcomes aren't met.

What makes Arcellx unique

  • Arcellx's CART-ddBCMA has Fast Track, Orphan Drug, and RMAT designations.
  • The ARC-SparX platform offers dosable and controllable CAR-T therapy options.
  • Anito-cel uses a novel D-Domain BCMA binder for enhanced antigen binding.

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