RA Specialist
RA Specialist
Leiden
Netherlands
Permanent
Manufacturing, Packaging & Production
1
Regulatory Affairs Specialist
Are you passionate about advancing groundbreaking cell therapies and navigating the complex regulatory landscape? Join our innovative biopharmaceutical company as a Regulatory Affairs (RA) Specialist in the rapidly evolving field of cell therapy!
About the Role
As our Cell Therapy RA Specialist, you will play a crucial role in ensuring regulatory compliance and facilitating the development and approval of novel cell-based therapies. You’ll work closely with cross-functional teams to develop regulatory strategies, prepare submissions, and interact with regulatory authorities.
Key Responsibilities
- Develop and implement regulatory strategies for cell therapy products in various stages of development
- Prepare and review regulatory submissions, including INDs, CTAs, and BLAs
- Interpret and apply regulatory guidelines and requirements specific to cell therapies
- Provide regulatory guidance to R&D, clinical, and manufacturing teams
- Interact with regulatory authorities and represent the company in regulatory meetings
- Stay current with evolving regulations and guidelines in the cell therapy space
Qualifications
- Advanced degree (Ph.D. or M.S.) in Life Sciences, preferably with a focus on cell biology or immunology
- Minimum of 5 years of experience in regulatory affairs, with specific expertise in cell therapies
- In-depth knowledge of FDA, EMA, and other international regulatory requirements for cell and gene therapies
- Strong understanding of GMP, GCP, and other relevant quality standards
- Excellent communication and interpersonal skills
- Ability to manage multiple projects and prioritize effectively
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.
Ryan Griffin
Submit Your CV
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