CAR-T Scientist for RA Manager (PARIS)

Regulatory Affairs Manager

Do to our client's exponential growth, they are looking for a Regulatory Affairs Manager with a strong scientific background in Gene and/or CAR T-cell therapies to lead and coordinate all RA activities for the implementation of the pre-clinical and early clinical development path for their main program.

Responsibilities

• Participate in the definition of the regulatory strategy, in close interaction with the CSO.
• Drafting scientific advice (EMA, FDA), clinical trial authorisation applications (Europe and US).
• Represent the company positions and interests in front of the competent authorities (e.g. EMA, FDA).
• Develop a network of external experts and coordinate interactions.
• Ensure continuous monitoring of applicable directives and regulations in force nationally and internationally and disseminate this information within the company.
• You will be cooperating with bio-production, R&D and pre-clinical research departments.
• Other related queries.

Qualifications

• Scientific background (Master of Science, postgraduate level minimum) with specialisation in regulatory affairs
• +5 years of experience in a bio-tech or pharma environment
• Experience in ATMP in cancer, preferably.
• Good command of English

Personal qualities

• Endowed with an enterprising, dynamic and operational spirit, you have a taste for challenge and a sense of responsibility.
• You demonstrate a high level of autonomy and pro-activity.
• Determined and organised.
• Strong team spirit and faculty to adapt together.
• Good communication skills.

Send your updated CV at a.lopez@nonstop-recruitment.com or call at +34 932 420 346 Extension: 3347 asking for Alejandro Lopez to get more details about the position.