Regulatory Compliance Expert

1 giorno fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
About the Role

We are seeking a highly skilled Regulatory Compliance Expert to join our team at Thermo Fisher Scientific. This is an exciting opportunity to work in a newly-established mRNA GMP manufacturing facility in Monza, Italy.

Responsibilities
  • Advise on licensing strategies for innovative mRNA products and partner with the Qualified Person to ensure regulatory compliance.
  • Develop and implement regulatory strategies to support the growth of the mRNA business entity.
  • Liaise with customers' technical and regulatory counterparts, promoting our services and facilitating regulatory-related activities.
Requirements
  • Bachelor's degree in Life Sciences (e.g., Pharmacy, Chemistry, Microbiology).
  • Minimum 7 years of experience in a regulatory role within the biopharmaceutical industry, ideally with exposure to ATMPs.
  • Well-versed on site licensing requirements for clinical and commercial bulk manufacturing according to AIFA, EMA, and FDA regulations.
What We Offer

As a Regulatory Compliance Expert at Thermo Fisher Scientific, you will have the opportunity to work in a dynamic environment with a global team. You will be responsible for ensuring adherence to key deliverables' regional plan, fostering into Global Regulatory Affairs reporting. The salary for this position is estimated to be around $120,000 per year, based on industry standards and location.



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