Simplify Logo

Full-Time

Associate Director

Regulatory Affairs CMC

Confirmed live in the last 24 hours

Arcellx

Arcellx

51-200 employees

Develops cell therapies for cancer, autoimmune diseases

Biotechnology
Healthcare

Compensation Overview

$165k - $180kAnnually

+ Bonus + Equity Grants + Relocation Assistance

Senior, Expert

North Bethesda, MD, USA

Relocation assistance offered if required.

Category
Biology Lab & Research
Biology & Biotech
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 innovative cell therapies for cancer and autoimmune diseases, leveraging their novel D-Domain technology and transformative ddCAR and ARC-SparX platforms to enhance cell therapy.

Company Stage

N/A

Total Funding

$736M

Headquarters

Gaithersburg, Maryland

Founded

2014

Growth & Insights
Headcount

6 month growth

24%

1 year growth

26%

2 year growth

78%
Simplify Jobs

Simplify's Take

What believers are saying

  • The Phase 3 iMMagine-3 trial for anito-cel could significantly boost Arcellx's market position if successful.
  • Recent robust long-term responses from the Phase 1 expansion trial of anito-cel indicate promising efficacy and safety, potentially leading to FDA approval.
  • The $285M equity investment and upfront cash from Kite provide substantial financial backing for Arcellx's ongoing and future projects.

What critics are saying

  • The competitive landscape for CAR T therapies is intense, with established players like Abecma and Carvykti posing significant challenges.
  • Regulatory hurdles, such as the recent FDA partial hold, could delay product development and market entry.

What makes Arcellx unique

  • Arcellx's anitocabtagene autoleucel (anito-cel) is the first BCMA CAR T therapy for multiple myeloma utilizing a novel D-Domain binder, setting it apart from existing treatments.
  • The company's strategic partnership with Kite, a Gilead Company, enhances its research capabilities and market reach, distinguishing it from smaller biotech firms.
  • Arcellx's focus on innovative immunotherapies for cancer and other incurable diseases positions it uniquely in the biotech landscape.