RA Specialist
RA Specialist
Leiden
Netherlands
Permanent
BioInformatics/BioStatistics
1
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
Submit Your CV
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