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Regulatory Affairs Specialist

BioTalent
Boston
2 days ago
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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 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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