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Principal Manager for Regulatory Strategies

2 months ago

Houston, Texas, United States Immatics NV Full time
Company Overview:

At Immatics NV, we are dedicated to innovation and excellence in the field of cellular therapies. Our mission is to develop groundbreaking solutions that enhance patient outcomes through advanced regulatory strategies.

Position Overview:

The Senior Manager of CMC Regulatory Affairs plays a pivotal role in shaping the regulatory framework for our cellular product candidates. This position requires close collaboration with various teams, including Process Development, Manufacturing, and Quality Assurance, to ensure compliance with regulatory standards.

Key Responsibilities:
  • Develop and implement regulatory CMC strategies for cellular products, addressing manufacturing process changes and validation efforts.
  • Author and maintain comprehensive CMC documentation for US INDs and EU CTAs, working alongside international project teams.
  • Prepare and respond to inquiries from regulatory authorities, ensuring clarity and compliance in all communications.
  • Facilitate Health Authority meetings by preparing necessary documentation and presentations from a regulatory perspective.
  • Evaluate and process change control procedures within the manufacturing domain.
  • Conduct thorough research and analysis of regulatory requirements, fostering effective cross-functional communication.
Additional Responsibilities:
  • Contribute to the development and review of Standard Operating Procedures (SOPs) and policies related to CMC Regulatory Affairs.
Qualifications:
  • A degree in a scientific discipline (e.g., biology, chemistry, or pharmacy) or a master's degree in Regulatory Affairs is preferred.
  • A minimum of 4 years of experience in Regulatory Affairs CMC, specifically for gene and cellular therapies.
  • Proven ability to coordinate tasks and work effectively in a highly regulated environment with international stakeholders.
  • Strong organizational and time management skills.
  • Excellent verbal and written communication abilities.
  • In-depth knowledge of global regulations and GMP guidelines.
Work Environment:

This role is primarily office-based, requiring the ability to engage in sedentary work for extended periods. The environment may include moderate noise levels and frequent use of office equipment.

Travel Requirements:
  • Occasional domestic and international travel may be necessary.
Legal Requirements:

Candidates must be legally eligible to work in the United States. Immatics NV participates in E-Verify and complies with all employment eligibility requirements.