Regulatory Affairs Specialist - Biologics & Gene Therapy

About the role

GRA CMC Specialist supporting Chemistry, Manufacturing & Controls activities for biologics and gene therapy programs.

Responsibilities

• Compile and review CMC data from analytical, process, and formulation development teams.
• Translate findings into high‑quality regulatory documents for IND/IMPD/BLA submissions and responses.
• Coordinate with Regulatory Affairs, QA, and Manufacturing to ensure compliance with global guidelines.
• Maintain robust documentation and data integrity.
• Assist in managing project timelines and risks within a collaborative, patient‑focused environment.

Qualifications

• Experience in CMC activities related to biologics or gene therapies.
• Strong understanding of regulatory documentation and submission processes.

Skills

• Excellent collaboration skills across cross‑functional teams.
• Attention to detail and commitment to data integrity.