RA Specialist

RA Specialist.

RA Specialist

Leiden

|

Permanent

|

BioInformatics/BioStatistics

Regulatory Affairs Specialist - Cell Therapy

Are you passionate about shaping the future of medicine through innovative cell therapies? We're seeking a talented Regulatory Affairs Specialist to join our dynamic team and help bring groundbreaking treatments to patients worldwide.

About the Role:

landscape for our cutting-edge products. You'll work closely with cross-functional teams to develop and implement regulatory strategies that accelerate our path to market while ensuring compliance with global regulations.

Key Responsibilities:

  • Develop and execute regulatory strategies for cell therapy products from clinical development through marketing authorization
  • Prepare and review regulatory submissions, including INDs, CTAs, and marketing applications
  • Lead interactions with regulatory agencies, including meeting preparation and follow-up
  • Monitor and analyze changes in the regulatory environment for cell and gene therapies
  • Provide regulatory guidance to internal teams on product development, manufacturing, and clinical trial design
  • Contribute to the preparation of regulatory documents, including briefing books and investigator brochures
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle

Qualifications:

  • Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred
  • 5+ years of experience in regulatory affairs, with specific expertise in cell therapy or regenerative medicine
  • In-depth knowledge of FDA, EMA, and other global regulatory requirements for cell therapies
  • Strong understanding of GMP, GCP, and other relevant quality standards
  • Excellent communication and interpersonal skills
  • Ability to manage multiple projects and prioritize effectively in a fast-paced environment

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

Ryan Griffin

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