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:As a Regulatory Affairs Specialist focusing on cell therapies, you’ll play a crucial role in navigating the complex regulatory 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