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