Regulatory Affairs Specialist

Overview

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.

You will have the opportunity to

• 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

Responsibilities

• 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

Qualifications

• 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science, Writing/Editing, and Manufacturing

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

Benefits

• Medical insurance
• Vision insurance
• 401(k)
• Tuition assistance
• Student loan assistance

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