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Associate Director, Regulatory Affairs CMC

2 months ago

Rockville, Maryland, United States Arcellx, Inc. Full time
Job Description

Company Overview

Arcellx, Inc. is a leading biotechnology company dedicated to developing innovative therapies for patients with severe diseases.

Job Summary

We are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our CMC (Chemistry, Manufacturing, and Control) products.

Key Responsibilities

  • Develop and implement regulatory strategies for CMC products, ensuring compliance with relevant regulations and guidelines.
  • Lead cross-functional teams to develop and submit regulatory documents, including INDs, NDAs, and BLAs.
  • Collaborate with internal stakeholders to ensure regulatory compliance and provide guidance on regulatory requirements.
  • Stay up-to-date with changing regulatory landscapes and provide recommendations for process improvements.

Requirements

  • Proven experience in regulatory affairs, with a focus on CMC products.
  • Strong knowledge of regulatory guidelines and regulations, including ICH, FDA, and EMA.
  • Excellent communication and leadership skills, with the ability to work effectively with cross-functional teams.
  • Ability to analyze complex data and develop effective solutions.

What We Offer

Arcellx, Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.