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Regulatory affairs specialist

Boston
BioTalent
Regulatory affairs specialist
Posted: 21h ago
Offer description

At BioTalent, we are working with a client exclusively to fill their RA Specialist position. They are a fast growing CGT company focused on developing products in the immuno-oncology. This role will focus on supporting their existing market with some NPD

You will be a key member of an established team.

This role will offer you

* To work in a fast-paced environment and the ability to take a huge impact.
* To work across global markets for new product introduction and post marketing
* High visibility from the senior leadership team including working directly with senior stakeholders

You will be responsible for

* For leading new product introduction into the US, Canada and EU
* Managing a small existing team with license to grow this further
* Regulatory strategy for new product innovation and maintenance of existing products

You will bring the following

* Hands on Regulatory experience within CGT products ideally with some opportunity for biologics candidate
* Hands on NDA, MAA and ideally BLA experience
* BSc or MSc in a relevant Life Sciences subject

If you want to be part of an innovative thinking, growing company where you can grow and expand your current knowledge, GET IN TOUCH - Please email me at michael.kakoullis@biotalent.com or on 857-391-6433 if you think you could be a good match.

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