Regulatory Compliance Expert
1 giorno fa
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.
- 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.
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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Director of Regulatory Compliance and Quality Assurance
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IT Compliance Expert
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GMP Equipment Compliance Specialist
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Environmental Health Specialist II Position
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